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Supplement Safety Checker

Is Your Supplement Safe?

Search 603 FDA warning letters. Independent safety reports compiled from official public records.

51
Critical
18
High Risk
534
Moderate
603
Total Reports

FDA Warning Letter Database

Nutritional Engineering Inc

September 29, 2017 · San Francisco District Office

Regulatory Violations

MODERATE

Soapwalla Inc.

September 28, 2017 · FDA

Regulatory Violations

MODERATE

Tenex Health

September 28, 2017 · FDA

Regulatory Violations

MODERATE

Total Body Nutrition

September 28, 2017 · New York District Office

Labeling Violations

CRITICAL

Rightway Nutrition, LLC

September 28, 2017 · FDA

Labeling Violations

MODERATE

Blue Ocean of Colorado, Inc.

September 28, 2017 · FDA

Regulatory Violations

MODERATE

Swagger Supps

September 28, 2017 · FDA

Labeling Violations

MODERATE

Rapid Release Technologies

September 27, 2017 · FDA

Regulatory Violations

MODERATE

Terra Biological LLC

September 27, 2017 · FDA

Labeling Violations

MODERATE

Hartley Medical Center Pharmacy, Incorporated

September 26, 2017 · FDA

Regulatory Violations

MODERATE

San Diego Compounding Pharmacy

September 25, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

UVLRX Therapeutics Inc

September 25, 2017 · Center for Devices and Radiological Health

Labeling Violations

MODERATE

Texas Plum Line

September 22, 2017 · Dallas District Office

Hidden Ingredients

CRITICAL

Nashoba Brook Bakery, LLC

September 22, 2017 · New York District Office

Labeling Violations

MODERATE

Aros Surgical Instruments Corporation

September 19, 2017 · FDA

Regulatory Violations

MODERATE

Wyeth Lederle S.p.A

September 18, 2017 · FDA

Regulatory Violations

MODERATE

Peter Thomas Roth Labs, LLC

September 18, 2017 · FDA

Regulatory Violations

MODERATE

Compounded Solutions in Pharmacy

September 18, 2017 · New England District Office

Regulatory Violations

MODERATE

VitaCare Pharma, LLC

September 15, 2017 · FDA

Regulatory Violations

MODERATE

Grandma's Herbs

September 15, 2017 · Denver District Office

Regulatory Violations

CRITICAL

MARUTOSHI

September 14, 2017 · FDA

Regulatory Violations

MODERATE

Jin Tzer Marine Products Co., LTD.

September 14, 2017 · FDA

Regulatory Violations

MODERATE

NutraClipse, Inc

September 13, 2017 · FDA

Labeling Violations

MODERATE

Applied Nutriceuticals

September 13, 2017 · FDA

Labeling Violations

MODERATE

Quick Foods Co.

September 13, 2017 · Chicago District Office

Adulteration, CGMP Violations, Contamination

HIGH

Rcba Nutraceuticals LLC

September 12, 2017 · FDA

Labeling Violations

MODERATE

Sea World, Inc.

September 12, 2017 · FDA

Regulatory Violations

MODERATE

Bodyhealth.com, LLC

September 12, 2017 · FDA

Labeling Violations

MODERATE

CooperSurgical, Inc.

September 12, 2017 · FDA

Regulatory Violations

MODERATE

SCS Direct Inc.

September 11, 2017 · FDA

Regulatory Violations

MODERATE

Homeocare Laboratories, Inc.

September 07, 2017 · New Jersey District Office

Regulatory Violations

MODERATE

New Capstone, Inc

September 07, 2017 · FDA

Regulatory Violations

MODERATE

T & L Creative Salads, Inc.

September 07, 2017 · FDA

Regulatory Violations

MODERATE

Newton Everett/WR Group Inc.

September 07, 2017 · Denver District Office

Regulatory Violations

CRITICAL

Mitsutoyo Co. Ltd., Hakodate Plant

September 07, 2017 · FDA

Regulatory Violations

MODERATE

Pharmakon Compounding Pharmacy, Inc.

September 07, 2017 · Detroit District Office

Regulatory Violations

MODERATE

Meridian Medical Technologies, Inc. a Pfizer Company

September 05, 2017 · Kansas City District Office

Adulteration, CGMP Violations, Labeling Violations

CRITICAL

ITG Brands, LLC

September 05, 2017 · FDA

Labeling Violations

MODERATE

Nova Homeopathic Therapeutics Inc

September 01, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Nd Labs, Inc.

September 01, 2017 · New York District Office

Labeling Violations

CRITICAL

Journey Health USA, LLC

September 01, 2017 · FDA

Labeling Violations

MODERATE

Achieve Health, LLC

September 01, 2017 · FDA

Labeling Violations

MODERATE

Eugene Airport

September 01, 2017 · FDA

Regulatory Violations

MODERATE

Green Roads of Florida LLC

October 31, 2017 · San Juan District Office

Regulatory Violations

CRITICAL

Stanley Brothers Social Enterprises, LLC

October 31, 2017 · Los Angeles District Office

Regulatory Violations

CRITICAL

That's Natural

October 31, 2017 · Los Angeles District Office

Regulatory Violations

CRITICAL

Natural Alchemist

October 31, 2017 · Los Angeles District Office

Regulatory Violations

CRITICAL

DPI Specialty Foods Rocky Mountain, Inc.

October 31, 2017 · FDA

Regulatory Violations

MODERATE

Lee K of NY Inc.

October 31, 2017 · FDA

Regulatory Violations

MODERATE

Wild Edibles Inc.

October 31, 2017 · FDA

Regulatory Violations

MODERATE

Royal Wine Corporation

October 31, 2017 · FDA

Regulatory Violations

MODERATE

NYSW Beverage Brands

October 31, 2017 · FDA

Regulatory Violations

MODERATE

P & L Distributor Inc. DBA Asia World Food Wholesale Company

October 30, 2017 · FDA

Regulatory Violations

MODERATE

Village Pharmacy

October 30, 2017 · New Jersey District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Madison Polymeric Engineering

October 26, 2017 · FDA

Regulatory Violations

MODERATE

Vedame Oils LLC dba UMA Oils

October 25, 2017 · FDA

Regulatory Violations

MODERATE

Dixon Fisheries Inc

October 24, 2017 · Chicago District Office

Adulteration, Hidden Ingredients

CRITICAL

Panther Sports Nutrition

October 23, 2017 · New Jersey District Office

Regulatory Violations

MODERATE

Magellan Diagnostics, Inc.

October 23, 2017 · New England District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Alexion Pharmaceuticals, Inc.

October 19, 2017 · FDA

Regulatory Violations

MODERATE

Thomas Veterinary Services PLC

October 19, 2017 · FDA

Regulatory Violations

MODERATE

Ameristar Casino Black Hawk

October 19, 2017 · FDA

Regulatory Violations

MODERATE

Cermaq Chile S.A. No. 10195

October 19, 2017 · FDA

Regulatory Violations

MODERATE

Caito Fisheries Inc

October 18, 2017 · FDA

Regulatory Violations

MODERATE

Accelerated Analytical Laboratories Inc.

October 18, 2017 · Detroit District Office

Regulatory Violations

MODERATE

Prismatik Dentalcraft, Inc

October 18, 2017 · FDA

Regulatory Violations

MODERATE

Express Diagnostics Int'l., Inc.

October 18, 2017 · FDA

Regulatory Violations

MODERATE

Pelvic Therapies, Inc

October 17, 2017 · Los Angeles District Office

Misbranding, Adulteration

MODERATE

Town and Country Compounding and Consultation Services, LLC

October 17, 2017 · New Jersey District Office

Regulatory Violations

MODERATE

Holmes Produce LLC DBA Holmes Made Salsa

October 17, 2017 · FDA

Regulatory Violations

MODERATE

Martin Avenue Pharmacy, Inc.

October 16, 2017 · FDA

Regulatory Violations

MODERATE

Kim Chemicals Private Ltd.

October 16, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Biomin Industries, Inc.

October 13, 2017 · Denver District Office

Labeling Violations

MODERATE

MBDR Foods, LLC

October 11, 2017 · FDA

Regulatory Violations

MODERATE

Yamashin Company, Ltd.

October 11, 2017 · FDA

Labeling Violations

MODERATE

Nubreed Nutrition, Inc

October 11, 2017 · FDA

Labeling Violations

MODERATE

Stanton Brothers

October 11, 2017 · FDA

Regulatory Violations

MODERATE

US Compounding Inc

October 10, 2017 · Dallas District Office

Regulatory Violations

MODERATE

Vital Laboratories Pvt Ltd Plant II

October 10, 2017 · Center for Drug Evaluation and Research

Regulatory Violations

MODERATE

Magadoo Corporation Co., Ltd.

October 06, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Kelyniam Global, Inc.

October 05, 2017 · New England District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

CRITICAL

Sekisui Medical Co., Ltd.

October 05, 2017 · FDA

CGMP Violations

MODERATE

Vet Cellect Bio Products, LLC

October 04, 2017 · New Jersey District Office

Adulteration, Labeling Violations

HIGH

King Systems Corp. dba Ambu, Inc.

October 04, 2017 · FDA

Regulatory Violations

MODERATE

Snyder's Lance Inc.

October 04, 2017 · Atlanta District Office

Labeling Violations

MODERATE

P & D Seafood Company Inc

October 03, 2017 · FDA

Regulatory Violations

MODERATE

The Santa Barbara Smokehouse, Inc.

October 03, 2017 · FDA

Regulatory Violations

MODERATE

Core Nutritionals

October 03, 2017 · FDA

Labeling Violations

MODERATE

Talon Compounding Pharmacy

October 03, 2017 · Dallas District Office

Regulatory Violations

MODERATE

Wellness Resources, Inc.

November 30, 2017 · Minneapolis District Office

Regulatory Violations

CRITICAL

TruVision Health LLC

November 29, 2017 · Denver District Office

Regulatory Violations

CRITICAL

Fagron Compounding Services LLC dba Fagron Sterile Services

November 28, 2017 · Detroit District Office

Regulatory Violations

MODERATE

Bear Creek Dairy Lp

November 27, 2017 · FDA

Regulatory Violations

MODERATE

Clements Foods Co

November 21, 2017 · FDA

Regulatory Violations

MODERATE

Repro-Med Systems, Inc.

November 20, 2017 · FDA

Regulatory Violations

MODERATE

Dae Young Foods Co., Ltd.

November 20, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

MEDDEV USA, INC.

November 2, 2017 · FDA

Regulatory Violations

MODERATE

Hangzhou Facecare Cosmetics Co., Ltd.

November 17, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Haldiram Snacks Pvt. Ltd.

November 17, 2017 · FDA

Regulatory Violations

MODERATE

Harbor Seafood Inc.

November 16, 2017 · FDA

Regulatory Violations

MODERATE

Naturefield Company Limited

November 16, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

U.L. Manufacturing Company Ltd.

November 16, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Granja La Cabana

November 14, 2017 · FDA

Regulatory Violations

MODERATE

Country Doctor Herbals

November 14, 2017 · FDA

Regulatory Violations

MODERATE

Mannatech Incorporated

November 14, 2017 · Dallas District Office

Regulatory Violations

MODERATE

Cau Tre Export Goods Processing Joint Stock Company

November 14, 2017 · FDA

Regulatory Violations

MODERATE

Quest Nutrition, LLC

November 13, 2017 · FDA

Labeling Violations

MODERATE

TSDR Pharmacy Inc. dba brandMD Skin Care

November 09, 2017 · Los Angeles District Office

Labeling Violations

MODERATE

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory

November 09, 2017 · FDA

Regulatory Violations

MODERATE

Vita Pure Inc

November 08, 2017 · Baltimore District Office

Adulteration, CGMP Violations, Labeling Violations

MODERATE

Divi's Laboratories Ltd. (Unit II)

November 07, 2017 · FDA

Regulatory Violations

MODERATE

Crop Pharms, LLC

November 07, 2017 · FDA

Regulatory Violations

MODERATE

Avena Botanicals, Inc.

November 07, 2017 · FDA

Regulatory Violations

MODERATE

Biotronik SE & Co. KG

November 06, 2017 · FDA

Regulatory Violations

MODERATE

Ba Hai Company Limited

November 03, 2017 · FDA

Regulatory Violations

MODERATE

Create-A-Pack Foods, Inc.

November 02, 2017 · Minneapolis District Office

Regulatory Violations

MODERATE

Medtronic Neuromodulation

November 02, 2017 · FDA

Regulatory Violations

MODERATE

Collagen Matrix, Inc.

November 01, 2017 · FDA

Regulatory Violations

MODERATE

Spinal Elements, Inc

November 01, 2017 · FDA

Regulatory Violations

MODERATE

Butts Dairy Farm

November 01, 2017 · Chicago District Office

Adulteration, Labeling Violations

MODERATE

Summit Nutritionals International

May 31, 2017 · New Jersey District Office

Regulatory Violations

MODERATE

NIDEK Co., Ltd., Hamacho Plant

May 26, 2017 · FDA

Regulatory Violations

MODERATE

Big Dan's Fitness / Nutrition, LLC

May 25, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

The Herbalist, Inc.

May 25, 2017 · Seattle District Office

Regulatory Violations

MODERATE

Life Rising Corporation

May 25, 2017 · Chicago District Office

Regulatory Violations

MODERATE

Herbal Doctor Remedies

May 25, 2017 · Los Angeles District Office

Regulatory Violations

CRITICAL

Yusef Manufacturing Laboratories, LLC

May 25, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Kanetoku Corporation

May 24, 2017 · FDA

Regulatory Violations

MODERATE

Visionary Contact Lens dba Visionary

May 24, 2017 · FDA

Regulatory Violations

MODERATE

CLA-COR Farms LLC

May 24, 2017 · FDA

Regulatory Violations

MODERATE

ICF International, LLC

May 23, 2017 · FDA

Labeling Violations

MODERATE

Adriatic Seafood Inc

May 23, 2017 · FDA

Regulatory Violations

MODERATE

A. I. Foods Corporation

May 23, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Bio TE Medical

May 22, 2017 · Dallas District Office

Regulatory Violations

MODERATE

Adamson Analytical Laboratories Inc

May 22, 2017 · FDA

Regulatory Violations

MODERATE

Masimo Corporation

May 22, 2017 · FDA

Regulatory Violations

MODERATE

AG Industries LLC

May 19, 2017 · FDA

Regulatory Violations

MODERATE

Kalloni S.A.

May 19, 2017 · FDA

Regulatory Violations

MODERATE

Etai's Food, Inc

May 19, 2017 · Denver District Office

Misbranding, Adulteration, Contamination, Hidden Ingredients, Labeling Violations

CRITICAL

YAMAHARU COMPANY

May 18, 2017 · FDA

Regulatory Violations

MODERATE

Med-Pharmex, Inc.

May 17, 2017 · Los Angeles District Office

Adulteration, CGMP Violations

MODERATE

TriOak Foods Inc

May 16, 2017 · FDA

Regulatory Violations

MODERATE

Rainbow Export Processing S.A.

May 16, 2017 · FDA

Regulatory Violations

MODERATE

Morhaim Pharmalab, Inc.

May 16, 2017 · Florida District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Ocubright Tear Stain Remover, Inc.

May 16, 2017 · Florida District Office

Adulteration, Labeling Violations

MODERATE

Baxter Healthcare Corporation

May 12, 2017 · FDA

Regulatory Violations

MODERATE

Merit Pet Products, LLC

May 12, 2017 · New England District Office

Adulteration, Labeling Violations

CRITICAL

Formulife, Inc.

May 12, 2017 · Dallas District Office

Misbranding, Labeling Violations

MODERATE

B. Braun Medical Inc

May 12, 2017 · Los Angeles District Office

Adulteration, CGMP Violations, Contamination

HIGH

VitaPurity Corporation

May 12, 2017 · Seattle District Office

Unapproved Drug Claims, Misbranding, Adulteration, CGMP Violations, Disease Claims, Labeling Violations

CRITICAL

Dougherty's Pharmacy

May 12, 2017 · Dallas District Office

Misbranding, Adulteration, CGMP Violations, Contamination, Labeling Violations

HIGH

Derrek Olson, LLC

May 10, 2017 · FDA

Regulatory Violations

MODERATE

Alexander Infusion LLC D/B/A Avanti Health Care

May 08, 2017 · FDA

Regulatory Violations

MODERATE

Zhejiang Biomet Medical Products Co. Ltd.

May 08, 2017 · FDA

Regulatory Violations

MODERATE

Nurse Assist, Inc

May 08, 2017 · Dallas District Office

Adulteration, CGMP Violations, Labeling Violations

MODERATE

Fenwal Inc

May 05, 2017 · FDA

Regulatory Violations

MODERATE

Fabrica de Conservas A Poveira, S.A.

May 05, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Barnier Production

May 05, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Rainbow Gold Products Inc

May 04, 2017 · New Orleans District Office

Regulatory Violations

MODERATE

SkyPeople Juice Group Co., Ltd

May 03, 2017 · FDA

Regulatory Violations

MODERATE

RESPONSE LETTER

May 03, 2017 · FDA

Adulteration, CGMP Violations

MODERATE

Accelerated Freeze Drying Co. Ltd.

May 02, 2017 · FDA

Regulatory Violations

MODERATE

Genus Medical Technologies

May 02, 2017 · Kansas City District Office

Unapproved Drug Claims, Misbranding, Labeling Violations, Fraudulent Claims

HIGH

Thor Inc.

May 01, 2017 · Denver District Office

Regulatory Violations

CRITICAL

WalkMed, LLC

May 01, 2017 · FDA

Regulatory Violations

MODERATE

Nature's Vision, Inc

May 01, 2017 · Detroit District Office

Unapproved Drug Claims, Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Bertrand Bulls

March 31, 2017 · FDA

Regulatory Violations

MODERATE

Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - #G03-1

March 31, 2003 · FDA

Labeling Violations

MODERATE

Vital Hierbas Naturales Corporation

March 30, 2018 · Chicago District Office

Unapproved Drug Claims, Misbranding, Labeling Violations

CRITICAL

Ozark Country Herbs

March 30, 2018 · Dallas District Office

CGMP Violations, Labeling Violations

CRITICAL

Tropic Fish Hawaii, LLC

March 30, 2018 · FDA

Regulatory Violations

MODERATE

South Texas Botanicals

March 29, 2018 · Dallas District Office

Labeling Violations

MODERATE

Hanbul Cosmetics Co., Ltd

March 29, 2018 · Center for Drug Evaluation and Research

Regulatory Violations

MODERATE

Targeted Medical Pharma, Inc. dba Physician Therapeutics

March 29, 2017 · Center for Drug Evaluation and Research

Labeling Violations

MODERATE

RESPONSE LETTER

March 29, 2017 · FDA

CGMP Violations, Hidden Ingredients, Labeling Violations

CRITICAL

RESPONSE LETTER

March 29, 2017 · FDA

Adulteration

MODERATE

Well Care Compounding Pharmacy

March 29, 2017 · San Francisco District Office

Regulatory Violations

MODERATE

Seiki Co., Ltd.

March 28, 2018 · FDA

Regulatory Violations

MODERATE

Stat Medical Devices, Inc.

March 28, 2018 · FDA

Regulatory Violations

MODERATE

SaveWay Compounding Pharmacy, Inc.

March 28, 2018 · FDA

Regulatory Violations

MODERATE

Ranier's Compounding Laboratory

March 28, 2017 · Philadelphia District Office

Regulatory Violations

MODERATE

Tai Heng Industry Co., Ltd.

March 27, 2017 · FDA

Regulatory Violations

MODERATE

Sanapac Co., Inc.

March 24, 2017 · Philadelphia District Office

Misbranding, Labeling Violations

CRITICAL

Cache Commodities Incorporated

March 23, 2018 · Denver District Office

Regulatory Violations

MODERATE

DBM Nutrition

March 23, 2018 · FDA

Labeling Violations

MODERATE

Nippon Fine Chemical Co., LTD

March 23, 2017 · FDA

Regulatory Violations

MODERATE

RESPONSE LETTER

March 23, 2017 · FDA

Adulteration, CGMP Violations

MODERATE

X12 Co., LTD.

March 23, 2017 · Center for Devices and Radiological Health

Adulteration, CGMP Violations, Labeling Violations

HIGH

Antioch Smoke Shop

March 21, 2017 · FDA

Misbranding, Labeling Violations

MODERATE

Swedish Tobacco

March 21, 2017 · FDA

Labeling Violations

MODERATE

Cross Street Tobacco

March 21, 2017 · FDA

Labeling Violations

MODERATE

Ba Hai Company Limited

March 21, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Vaping Sisters

March 21, 2017 · FDA

Labeling Violations

MODERATE

Vacunda & Design

March 20, 2017 · San Juan District Office

Misbranding, Labeling Violations

CRITICAL

Matthew Brennan

March 17, 2017 · FDA

Regulatory Violations

MODERATE

Eurotrol B. V.

March 17, 2017 · FDA

Regulatory Violations

MODERATE

Gentell, Inc

March 16, 2017 · FDA

Regulatory Violations

MODERATE

Chen Shwezin, Inc. dba Park Compounding Pharmacy

March 15, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Nutri-Dyn Midwest, Inc.

March 15, 2017 · FDA

Regulatory Violations

MODERATE

MIYAQUIL SA

March 15, 2017 · Center for Food Safety and Applied Nutrition

Adulteration

MODERATE

Nikki's Ginger Tea LLC

March 14, 2018 · FDA

Regulatory Violations

MODERATE

Jack Van Drie

March 14, 2017 · FDA

Regulatory Violations

MODERATE

Armada Nutrition

March 13, 2018 · FDA

CGMP Violations

MODERATE

Biotek, Inc.

March 13, 2018 · Denver District Office

Labeling Violations

MODERATE

Zarbee's Naturals Inc.

March 13, 2018 · FDA

Regulatory Violations

MODERATE

Electronic-cigz

March 13, 2017 · FDA

Labeling Violations

MODERATE

E-cigarettescn.co

March 13, 2017 · FDA

Labeling Violations

MODERATE

Bootleg Vapors

March 13, 2017 · FDA

Labeling Violations

MODERATE

E-Cigarette-Sellers.com

March 13, 2017 · FDA

Labeling Violations

MODERATE

Tampa Humidor

March 13, 2017 · FDA

Labeling Violations

MODERATE

The One Stop Vapor Shop

March 13, 2017 · FDA

Labeling Violations

MODERATE

Raritan Pharmaceuticals, Inc.

March 12, 2018 · FDA

Regulatory Violations

MODERATE

Dreamland Trading Inc

March 10, 2017 · FDA

Regulatory Violations

MODERATE

Carol Bond Health Foods

March 09, 2018 · Dallas District Office

Regulatory Violations

MODERATE

Olympus Medical Systems Corporation

March 09, 2018 · Center for Devices and Radiological Health

Regulatory Violations

MODERATE

Hoya Corporation - Pentax Life Division

March 09, 2018 · Center for Devices and Radiological Health

Regulatory Violations

MODERATE

Labocont Industrial SRL

March 09, 2018 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Reliable Rexall-A Compounding Pharmacy

March 09, 2017 · San Francisco District Office

Regulatory Violations

MODERATE

C & B Croissants Corporation

March 09, 2017 · Los Angeles District Office

Adulteration, CGMP Violations, Contamination

HIGH

Electronic Cigarettes, Inc.

March 07, 2017 · FDA

Labeling Violations

MODERATE

JDL Engineering Associates Incorporated

March 07, 2017 · FDA

Labeling Violations

MODERATE

4C Foods Corp.

March 06, 2018 · FDA

Regulatory Violations

MODERATE

MedPark Pharmacy, LLC

March 05, 2018 · New Jersey District Office

Regulatory Violations

MODERATE

God Quest, Inc. d/b/a Creation Today

March 05, 2018 · FDA

Regulatory Violations

MODERATE

Lincare, Inc.

March 05, 2018 · FDA

Regulatory Violations

MODERATE

Louisville Reproductive Center

March 05, 2018 · FDA

Regulatory Violations

MODERATE

Navinta, LLC

March 05, 2018 · FDA

Regulatory Violations

MODERATE

Maria Distribution Sarl

March 03, 2017 · FDA

Regulatory Violations

MODERATE

Proceconsa S.A. Procesadora Continental de Alimentos S.A.

March 03, 2017 · FDA

Regulatory Violations

MODERATE

Bateman's Mosida Farms LLC

March 03, 2017 · FDA

Regulatory Violations

MODERATE

The Cookie Boys

March 03, 2017 · San Francisco District Office

Regulatory Violations

MODERATE

Formulife, Inc.

March 02, 2018 · FDA

Regulatory Violations

MODERATE

KCE LLC

March 02, 2018 · FDA

Regulatory Violations

MODERATE

Healing Noni Co., LLC

March 02, 2018 · FDA

Regulatory Violations

MODERATE

Tata Harper Skincare

March 02, 2017 · FDA

Regulatory Violations

MODERATE

Cape Fear Naturals

March 02, 2017 · Atlanta District Office

Regulatory Violations

CRITICAL

Badrivishal Chemicals & Pharmaceuticals

March 02, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Lumis Global Pharmaceuticals Co. Ltd.

March 02, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Insulet Corporation

March 02, 2017 · FDA

Regulatory Violations

MODERATE

Kosher Vitamin Express

March 01, 2018 · FDA

Labeling Violations

MODERATE

Pharmacy Resources Incorporated

March 01, 2018 · Los Angeles District Office

Regulatory Violations

MODERATE

Corey Kay

June 30, 2017 · FDA

Regulatory Violations

MODERATE

Blends Maker Manufacturing Inc

June 30, 2017 · FDA

Regulatory Violations

MODERATE

Nanosphere, Inc.

June 30, 2017 · FDA

Regulatory Violations

MODERATE

Nature's Health Company, LLC

June 30, 2017 · Cincinnati District Office

Regulatory Violations

CRITICAL

Azienda Agricola Paul Cappelli

June 30, 2017 · FDA

Regulatory Violations

MODERATE

Evanger's Dog & Cat Food Co

June 29, 2017 · Chicago District Office

Adulteration, CGMP Violations, Contamination

HIGH

God Quest, Inc. d/b/a Creation Today

June 29, 2017 · San Juan District Office

Regulatory Violations

CRITICAL

PARAYIL FOOD PRODUCTS PVT. LTD.

June 28, 2017 · FDA

Regulatory Violations

MODERATE

Human Evolution Supplements

June 28, 2017 · FDA

Regulatory Violations

MODERATE

Prescription Lab Compounding Pharmacy

June 27, 2017 · FDA

Regulatory Violations

MODERATE

New Capstone, Inc

June 27, 2017 · Los Angeles District Office

Regulatory Violations

CRITICAL

Royal Foods

June 27, 2017 · FDA

Regulatory Violations

MODERATE

Smoked Seafood, Inc. dba Little Mermaid Smokehouse

June 27, 2017 · Los Angeles District Office

Labeling Violations

MODERATE

Fresh Directions Dominicana S.A.

June 22, 2017 · FDA

Regulatory Violations

MODERATE

Yuet Heung Yuen (ZhuHai) Ltd.

June 21, 2017 · FDA

Regulatory Violations

MODERATE

St. Shine Optical Co., Ltd

June 21, 2017 · FDA

Regulatory Violations

MODERATE

LifeSilver

June 21, 2017 · FDA

Labeling Violations

MODERATE

Steiner Laboratories

June 21, 2017 · Center for Devices and Radiological Health

Regulatory Violations

HIGH

Raritan Pharmaceuticals, Inc.

June 20, 2017 · New Jersey District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Nam Sun Fisheries Co.

June 16, 2017 · FDA

Regulatory Violations

MODERATE

Pranas S.A.

June 15, 2017 · FDA

Regulatory Violations

MODERATE

Soapwalla Inc.

June 15, 2017 · Center for Food Safety and Applied Nutrition

Labeling Violations

MODERATE

Shanghai Desano Chemical Pharmaceutical Co., Ltd.

June 14, 2017 · FDA

Regulatory Violations

MODERATE

Nutreglo Products, Inc.

June 14, 2017 · FDA

Labeling Violations

MODERATE

Hsu's Ginseng Enterprises, Inc

June 13, 2017 · FDA

Regulatory Violations

MODERATE

Hospira Spa

June 13, 2017 · FDA

Regulatory Violations

MODERATE

Valeant Pharmacueticals International

June 13, 2017 · FDA

Regulatory Violations

MODERATE

NanoBiotech Pharma

June 13, 2017 · FDA

Labeling Violations

MODERATE

Top Secret Nutrition LLC

June 13, 2017 · FDA

Regulatory Violations

MODERATE

STI Pharma LLC

June 12, 2017 · FDA

Regulatory Violations

MODERATE

Cepheid Ab

June 12, 2017 · FDA

Regulatory Violations

MODERATE

Coapt LLC

June 12, 2017 · FDA

Regulatory Violations

MODERATE

Belmora LLC

June 08, 2017 · Baltimore District Office

Regulatory Violations

MODERATE

Xcel Sports Nutrition, LLC

June 08, 2017 · Dallas District Office

Regulatory Violations

MODERATE

Sandoz Private Limited

June 08, 2017 · FDA

Regulatory Violations

MODERATE

Pressure Safe, LLC

June 07, 2017 · Seattle District Office

Adulteration

MODERATE

Olympus Medical Systems Corporation

June 07, 2017 · FDA

Regulatory Violations

MODERATE

Yamahide Shokuhin, Inc.

June 06, 2017 · FDA

Regulatory Violations

MODERATE

Omron (Dalian) Co., Ltd. (Plant 1)

June 05, 2017 · FDA

Regulatory Violations

MODERATE

Jeni's Splendid Ice Creams, LLC

June 02, 2017 · FDA

Regulatory Violations

MODERATE

Zhejiang Hisun Pharmaceutical Co., Ltd.

June 01, 2017 · FDA

Regulatory Violations

MODERATE

Powder City LLC

June 01, 2017 · FDA

Regulatory Violations

MODERATE

Crimasa Criaderos De Mariscos S. A.

June 01, 2017 · FDA

Regulatory Violations

MODERATE

Seiki Co., Ltd.

June 01, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Post Winery, Inc.

July 28, 2017 · FDA

Regulatory Violations

MODERATE

Physician Preferred Medical, LLC

July 28, 2017 · FDA

Regulatory Violations

MODERATE

American Specialty Pharmacy

July 28, 2017 · FDA

Regulatory Violations

MODERATE

JW Nutritional LLC Dallas

July 28, 2017 · FDA

Regulatory Violations

MODERATE

Skin Sciences Laboratory, Inc.

July 28, 2017 · Center for Drug Evaluation and Research

Regulatory Violations

MODERATE

Fusipim Sdn. Bhd.

July 27, 2017 · FDA

Regulatory Violations

MODERATE

Unicord Public Company Ltd.

July 26, 2017 · FDA

Regulatory Violations

MODERATE

Seaview Fisheries Inc. dba Seaview Lobster Co.

July 26, 2017 · FDA

Regulatory Violations

MODERATE

Agroindustrias Mora S.A.

July 26, 2017 · FDA

Regulatory Violations

MODERATE

Fresenius Kabi USA, LLC

July 26, 2017 · FDA

Regulatory Violations

MODERATE

BULCONS PARVOMAY AD

July 26, 2017 · FDA

Regulatory Violations

MODERATE

Portland Fish Exchange

July 26, 2017 · FDA

Regulatory Violations

MODERATE

Southeast Asian Packaging and Canning Limited.

July 25, 2017 · FDA

Regulatory Violations

MODERATE

Morwai Dairy

July 25, 2017 · FDA

Regulatory Violations

MODERATE

Mylan Laboratories Limited

July 24, 2017 · FDA

Regulatory Violations

MODERATE

CHUNGDO PHARM. CO. LTD.

July 21, 2017 · FDA

Regulatory Violations

MODERATE

Twin Falls Biotech LLC

July 21, 2017 · FDA

Labeling Violations

MODERATE

Morales Fishco

July 21, 2017 · FDA

Regulatory Violations

MODERATE

Amafruits

July 21, 2017 · Chicago District Office

Regulatory Violations

CRITICAL

Option Care

July 20, 2017 · New Jersey District Office

Adulteration, Contamination

HIGH

Belmora LLC

July 19, 2017 · FDA

Regulatory Violations

MODERATE

Be Natural Organics

July 19, 2017 · Chicago District Office

Labeling Violations

MODERATE

Vedame Oils LLC dba UMA Oils

July 18, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Pesca Fina, S.A.

July 18, 2017 · Center for Food Safety and Applied Nutrition

Adulteration

CRITICAL

Terra Biological LLC

July 18, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Algunas Inc., dba Woodland Hills Compounding Pharmacy

July 17, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Lopez Gonzalez Santana Corporation dba Domel and dba Dermixx

July 16, 2018 · San Juan District Office

Regulatory Violations

MODERATE

R & R Holsteins, LLC (Dairy #3)

July 16, 2017 · Seattle District Office

Adulteration, Labeling Violations

MODERATE

Whitestone Feeds LLC

July 14, 2017 · Cincinnati District Office

Adulteration, CGMP Violations

MODERATE

Strictly Health Corp

July 13, 2017 · FDA

Labeling Violations

MODERATE

K S Choi Corp

July 13, 2017 · FDA

Regulatory Violations

MODERATE

Fishermans Market Ltd.

July 13, 2017 · FDA

Regulatory Violations

MODERATE

Celtrock Holdings Limited

July 12, 2017 · FDA

Regulatory Violations

MODERATE

Improva Herbal Products

July 12, 2017 · FDA

Regulatory Violations

MODERATE

Zhucheng Haotian Pharm Co., Ltd.

July 12, 2017 · FDA

Regulatory Violations

MODERATE

Tentay Food Sauces, Inc.

July 11, 2017 · FDA

Regulatory Violations

MODERATE

Black Seed Herb, Inc.

July 11, 2017 · New York District Office

Misbranding, CGMP Violations, Labeling Violations

MODERATE

MasterPharm LLC

July 07, 2017 · FDA

Regulatory Violations

MODERATE

Miracle in the Green

July 06, 2017 · FDA

Regulatory Violations

MODERATE

Irie Star LLC

July 06, 2017 · Kansas City District Office

Regulatory Violations

MODERATE

APS BioGroup, Inc

July 06, 2017 · Los Angeles District Office

Unapproved Drug Claims, Misbranding, Labeling Violations

MODERATE

Professional Botanicals, Inc.

July 06, 2017 · Denver District Office

Labeling Violations

MODERATE

Haldiram Snacks Pvt. Ltd.

July 06, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Prestige Brands Holdings

July 05, 2017 · FDA

Regulatory Violations

MODERATE

Lac-Mac Limited

July 03, 2017 · FDA

Regulatory Violations

MODERATE

Frontier Japan Inc.

January 31, 2017 · FDA

Regulatory Violations

MODERATE

Whole Foods Market North Atlantic Kitchen

January 30, 2017 · FDA

Regulatory Violations

MODERATE

Huvepharma Inc

January 30, 2017 · FDA

Regulatory Violations

MODERATE

Pentax of America, Inc.

January 26, 2018 · FDA

Regulatory Violations

MODERATE

m4 Nutrition Companies LLC

January 26, 2018 · FDA

Labeling Violations

MODERATE

Light Age, Inc.

January 24, 2018 · New England District Office

Adulteration, CGMP Violations

HIGH

Young Health Products

January 24, 2018 · Dallas District Office

Regulatory Violations

CRITICAL

Herbal Energetics/In Joy Organics

January 24, 2017 · FDA

Regulatory Violations

MODERATE

Nam & Nam, Inc. t/a Sam Sung Tofu

January 24, 2017 · Baltimore District Office

Misbranding, Labeling Violations

MODERATE

Herbal Science International, Inc.

January 23, 2017 · Los Angeles District Office

Labeling Violations

MODERATE

Reasy Farms

January 20, 2017 · FDA

Regulatory Violations

MODERATE

Empire Crab Company, Inc

January 20, 2017 · FDA

Regulatory Violations

MODERATE

Miami Fat Supply, Inc

January 19, 2018 · FDA

Regulatory Violations

MODERATE

Enclara Pharmacia Inc

January 19, 2018 · FDA

Adulteration, CGMP Violations

MODERATE

Finally Pure, LLC

January 17, 2017 · FDA

Regulatory Violations

MODERATE

E-Cig Company

January 17, 2017 · Center for Tobacco Products

Regulatory Violations

MODERATE

Fleming Laboratories Ltd.

January 15, 2017 · FDA

Regulatory Violations

MODERATE

PerkinElmer Health Sciences, Inc.

January 13, 2017 · FDA

Regulatory Violations

MODERATE

Beauty Manufacturing Solutions Corp.

January 12, 2018 · Dallas District Office

Adulteration, CGMP Violations, Labeling Violations

MODERATE

BioModeling Solutions, Inc.

January 12, 2018 · Los Angeles District Office

Misbranding, Adulteration, CGMP Violations

MODERATE

King of Pops

January 12, 2018 · FDA

Regulatory Violations

MODERATE

Wong Lap Kwong Medicine Company Limited

January 11, 2018 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Opiate Freedom Center

January 11, 2018 · Center for Food Safety and Applied Nutrition

Misbranding, Health Claims

MODERATE

U4Life LLC dba Mitadone

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

CalmSupport.com, LLC

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

TaperAid

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Medicus Holistic Alternatives LLC

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

NutraCore Health Products

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Healthy Healing dba Crystal Star

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Soothedrawal, Inc.

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Choice Detox Center, Inc. dba Nofeel

January 11, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Plainsboro Pharmacy

January 11, 2017 · FDA

Regulatory Violations

MODERATE

ITW Dymon

January 11, 2017 · FDA

Regulatory Violations

MODERATE

Fisk Seafood ehf

January 11, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Topspins, Inc.

January 11, 2017 · FDA

Regulatory Violations

MODERATE

USA Labs AKA Power Source Distributors, Inc AKA USA Sport

January 10, 2018 · Cincinnati District Office

Regulatory Violations

CRITICAL

Ital Lemon

January 10, 2018 · FDA

Regulatory Violations

MODERATE

Pesquera Nivama SAC

January 10, 2018 · FDA

Regulatory Violations

MODERATE

PT Sukses Sejati

January 09, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

PT Anugerah Lestari Abadi

January 09, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

PT Sekar Subur Abadi

January 09, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

PT Shimasse Prata Citra

January 09, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Pt Tritos Sejahtera

January 09, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

pt Mitra T.N.

January 09, 2018 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Access Bio, Inc.

January 09, 2017 · FDA

Regulatory Violations

MODERATE

Wellmill LLC dba Vitamix

January 09, 2017 · FDA

Regulatory Violations

MODERATE

Sato Yakuhin Kogyo Co., Ltd.

January 06, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Suzhou Pharmaceutical Technology Co.,Ltd

January 06, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Wellington Foods

January 06, 2017 · Los Angeles District Office

Labeling Violations

MODERATE

Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc.

January 05, 2018 · Seattle District Office

Regulatory Violations

CRITICAL

Besa ehf

January 05, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Compania Pesquera Charly, SA dba Copescharly, SA

January 05, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

American CryoStem Corporation

January 03, 2018 · Florida District Office

Regulatory Violations

MODERATE

Sucesores De Esmoris & Co., Inc.

January 02, 2018 · FDA

Regulatory Violations

MODERATE

Hahn's Old Fashioned Cake Company, Inc.

February 28, 2018 · FDA

Regulatory Violations

MODERATE

Northern Fish Products, Inc.

February 28, 2018 · FDA

Regulatory Violations

MODERATE

TS Food Industry Sdn. Bhd.

February 28, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Seafood Wholesalers, Limited

February 27, 2018 · FDA

Regulatory Violations

MODERATE

Laser Dental Innovations

February 27, 2018 · Los Angeles District Office

Adulteration, CGMP Violations

MODERATE

Jinan Jinda Pharmaceutical Chemistry Co., Ltd.

February 24, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Megafine Pharma (P) Limited

February 24, 2017 · Center for Drug Evaluation and Research

Adulteration

MODERATE

Sterling USA Nutraceuticals Lab, LLC

February 24, 2017 · FDA

Regulatory Violations

MODERATE

PA Constans - Minnesota Emu

February 23, 2018 · Minneapolis District Office

Regulatory Violations

CRITICAL

Sherman's 1400 Broadway, N.Y.C. LLC.

February 23, 2018 · FDA

Labeling Violations

MODERATE

River Valley Dairy

February 23, 2017 · FDA

Regulatory Violations

MODERATE

Hillcrest Homestead LLC

February 23, 2017 · FDA

Regulatory Violations

MODERATE

Parker's Dairy Inc.

February 23, 2017 · FDA

Regulatory Violations

MODERATE

Vansridge Dairy

February 23, 2017 · FDA

Regulatory Violations

MODERATE

Sharp Global Limited

February 21, 2017 · FDA

Regulatory Violations

MODERATE

S.A.R.L. Pacific Tuna

February 21, 2017 · FDA

Regulatory Violations

MODERATE

Hochico Marine Processing Corp.

February 21, 2017 · FDA

Regulatory Violations

MODERATE

N.V.E. Pharmaceuticals, Inc.

February 21, 2017 · FDA

Regulatory Violations

MODERATE

Pearson Foods Corporation

February 20, 2018 · FDA

Regulatory Violations

MODERATE

Gilchrist & Soames

February 20, 2018 · FDA

Regulatory Violations

MODERATE

Homeodynamics, LLC

February 20, 2018 · Minneapolis District Office

Regulatory Violations

MODERATE

Neo Vision Co Ltd

February 20, 2018 · FDA

Labeling Violations

MODERATE

Evanger's Dog & Cat Food Co

February 16, 2018 · FDA

Regulatory Violations

MODERATE

Arcadia Trading Inc.

February 16, 2018 · FDA

Regulatory Violations

MODERATE

Ricker Hill Farms

February 15, 2018 · New York District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Finemost Corporation

February 15, 2018 · FDA

Regulatory Violations

MODERATE

Vertebral Technologies, Inc.

February 15, 2017 · FDA

Regulatory Violations

MODERATE

Faye's Texas Naturals

February 15, 2017 · FDA

Regulatory Violations

MODERATE

Empacadora Diamante S.A.

February 14, 2018 · FDA

Regulatory Violations

MODERATE

Usv Limited

February 14, 2018 · FDA

Regulatory Violations

MODERATE

Chongqing Pharma Research Institute Co., Ltd.

February 14, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

COTRONIC Technology Limited

February 14, 2017 · FDA

Regulatory Violations

MODERATE

LifeCell Corporation

February 14, 2017 · FDA

Labeling Violations

MODERATE

GVS Filter Technology UK Ltd

February 14, 2017 · FDA

Regulatory Violations

MODERATE

WD Import and Export Inc.

February 13, 2018 · FDA

Regulatory Violations

MODERATE

Casmara Cosmetics, S.A.

February 12, 2018 · Center for Drug Evaluation and Research

Regulatory Violations

MODERATE

Baxter Healthcare Renal Div

February 10, 2017 · FDA

Regulatory Violations

MODERATE

Bluemist, LLC

February 10, 2017 · FDA

Labeling Violations

MODERATE

Blak Ecig Inc

February 10, 2017 · FDA

Labeling Violations

MODERATE

True Vapes, LLC

February 10, 2017 · FDA

Labeling Violations

MODERATE

Pakco (Pty) Ltd.

February 09, 2018 · FDA

Regulatory Violations

MODERATE

Balfego and Balfego, SL

February 09, 2018 · FDA

Regulatory Violations

MODERATE

Corin Ltd

February 09, 2017 · FDA

Regulatory Violations

MODERATE

Moy-Fincher Medical Group

February 08, 2018 · FDA

Labeling Violations

MODERATE

Humaworm

February 08, 2017 · New Orleans District Office

Regulatory Violations

CRITICAL

Hookah Town

February 08, 2017 · FDA

Labeling Violations

MODERATE

Encore Vapor Inc

February 08, 2017 · FDA

Labeling Violations

MODERATE

Baxter Healthcare Corp.

February 08, 2017 · FDA

Regulatory Violations

MODERATE

Puff N Stuff Kissimmee Inc.

February 08, 2017 · FDA

Labeling Violations

MODERATE

QL FIGO FOODS SDN BHD

February 07, 2018 · FDA

Regulatory Violations

MODERATE

Shanghai Weierya Daily Chemicals Factory

February 07, 2018 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Magadoo Corporation Co., Ltd.

February 07, 2018 · FDA

Regulatory Violations

MODERATE

Reishi D. International, Inc.

February 06, 2018 · San Francisco District Office

Labeling Violations

MODERATE

Saputo Dairy Foods USA, LLC

February 06, 2017 · FDA

Regulatory Violations

MODERATE

Americare Compounding, LLC.

February 06, 2017 · FDA

Regulatory Violations

MODERATE

Infant Acid Reflux Solutions LLC

February 05, 2018 · Los Angeles District Office

Regulatory Violations

MODERATE

Conrad Shada

February 03, 2017 · FDA

Regulatory Violations

MODERATE

Avella of Deer Valley, Inc. dba Avella

February 03, 2017 · FDA

Regulatory Violations

MODERATE

Resonance Laboratories Private Limited

February 03, 2017 · Center for Drug Evaluation and Research

Regulatory Violations

MODERATE

Gary Manternach Farm

February 03, 2017 · FDA

Regulatory Violations

MODERATE

DoctorVicks.com

February 02, 2018 · FDA

Regulatory Violations

MODERATE

Cosmecca Korea Co., Ltd.

February 02, 2018 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Hsien-Pin Frozen Foods Co., Ltd.

February 02, 2018 · FDA

Regulatory Violations

MODERATE

Flying Food Group, LLC.

February 02, 2018 · FDA

Regulatory Violations

MODERATE

Compumedics Germany Gmbh

February 02, 2017 · FDA

Regulatory Violations

MODERATE

Total Evapes & Coffee

February 02, 2017 · FDA

Labeling Violations

MODERATE

Sewaren Innovative Pharmaceutical Packaging dba SIPP

February 01, 2018 · FDA

Regulatory Violations

MODERATE

Life Extension Foundation Buyers Club, Inc.

February 01, 2017 · Florida District Office

Regulatory Violations

MODERATE

Transbuana International Express

December 29, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

PT. GALAXY NUSA DUA

December 29, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

PT. Nusantara Jaya Abadi

December 29, 2017 · Center for Food Safety and Applied Nutrition

Regulatory Violations

MODERATE

Mahard Egg Farm, Inc. (Boogie Hill)

December 22, 2017 · FDA

Regulatory Violations

MODERATE

Oakdell Pharmacy, Inc

December 21, 2017 · FDA

Regulatory Violations

MODERATE

Imprimis Pharmaceuticals

December 21, 2017 · Center for Drug Evaluation and Research

Misbranding, Labeling Violations

HIGH

Optimum Bioenergy International Corp.

December 21, 2017 · San Francisco District Office

Regulatory Violations

MODERATE

Schrofner Cosmetics Gmbh

December 20, 2017 · Center for Drug Evaluation and Research

Labeling Violations

MODERATE

Maine Natural Health, Inc.

December 19, 2017 · New York District Office

Regulatory Violations

CRITICAL

C. O. Truxton Inc.

December 19, 2017 · New Jersey District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Delta Laboratories Pty Ltd

December 19, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Neilsen Seafood

December 19, 2017 · Cincinnati District Office

Labeling Violations

MODERATE

Double Tree Dairy Farm, LLC

December 18, 2017 · FDA

Regulatory Violations

MODERATE

Prosana Distribuciones SA de CV

December 17, 2017 · Center for Drug Evaluation and Research

Unapproved Drug Claims, Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Gold Star Smoked Fish Corp.

December 15, 2017 · New York District Office

Adulteration, Contamination

CRITICAL

Elite Laboratories Inc.

December 15, 2017 · FDA

Regulatory Violations

MODERATE

Eden’s Answers Inc. and Sprigs Life Inc.

December 14, 2017 · Cincinnati District Office

Labeling Violations

MODERATE

Chemolee Lab Corporation

December 14, 2017 · FDA

Regulatory Violations

MODERATE

BrainAlert, LLC

December 14, 2017 · Seattle District Office

Regulatory Violations

CRITICAL

Van Oriental Food, Inc

December 13, 2017 · FDA

Regulatory Violations

MODERATE

Dynamic Technical Formulations

December 13, 2017 · Atlanta District Office

Regulatory Violations

MODERATE

GnuPharma Corp.

December 13, 2017 · Dallas District Office

Regulatory Violations

MODERATE

Amaros Co., Ltd

December 13, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Arco Globus Trading LLC

December 11, 2017 · Center for Drug Evaluation and Research

Unapproved Drug Claims, Misbranding, Hidden Ingredients, Labeling Violations

CRITICAL

Seafood Supply Company, LP Respone Letter 12/10/12

December 10, 2012 · FDA

Regulatory Violations

MODERATE

K & S Food Center LLC

December 08, 2017 · New York District Office

Adulteration, CGMP Violations

MODERATE

High Spot Health Technology Co. Ltd.

December 07, 2017 · FDA

Regulatory Violations

MODERATE

Meditech Laboratories, Inc

December 06, 2017 · FDA

Regulatory Violations

MODERATE

Eagle Smoked Salmon, Inc.

December 05, 2017 · FDA

Regulatory Violations

MODERATE

Seindni Co., Ltd.

December 05, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Bedessee Imports, Inc

December 01, 2017 · New York District Office

Labeling Violations

CRITICAL

BBS Pharmacy, Inc. dba B&B Pharmacy

August 31, 2017 · FDA

Regulatory Violations

MODERATE

TEI Biosciences

August 31, 2017 · FDA

Labeling Violations

MODERATE

Firson Co., Ltd.

August 31, 2017 · Center for Drug Evaluation and Research

Contamination

HIGH

Home Care Pharmacy of Palm Coast, Inc.

August 31, 2017 · Dallas District Office

Misbranding, Adulteration, CGMP Violations, Contamination, Labeling Violations

HIGH

MusclMasster, LLC

August 30, 2017 · Denver District Office

Labeling Violations

CRITICAL

bioMerieux, Inc.

August 30, 2017 · FDA

Regulatory Violations

MODERATE

TS Food Industry Sdn. Bhd.

August 29, 2017 · FDA

Regulatory Violations

MODERATE

Burkmann Industries Inc.

August 29, 2017 · Cincinnati District Office

CGMP Violations

MODERATE

Anybattery, Inc.

August 28, 2017 · FDA

Regulatory Violations

MODERATE

American Medical Systems, LLC

August 25, 2017 · FDA

Regulatory Violations

MODERATE

FACTA Farmaceutici S.p.A.

August 25, 2017 · FDA

Regulatory Violations

MODERATE

Cermaq Chile S.A. No. 10195

August 25, 2017 · Center for Food Safety and Applied Nutrition

Adulteration

MODERATE

Best Seasonings Group, Inc.

August 24, 2017 · FDA

Regulatory Violations

MODERATE

Nautical Foods, LLC

August 24, 2017 · Baltimore District Office

Adulteration, CGMP Violations, Contamination, Hidden Ingredients, Labeling Violations

CRITICAL

US Stem Cell Clinic, LLC

August 24, 2017 · Florida District Office

Adulteration, CGMP Violations, Labeling Violations

MODERATE

Trinity Sports Group, Inc.

August 24, 2017 · FDA

Regulatory Violations

MODERATE

Vicrossano Inc.

August 22, 2017 · FDA

Regulatory Violations

MODERATE

SDC Nutrition Inc

August 22, 2017 · FDA

Labeling Violations

MODERATE

Louie Foods International

August 21, 2017 · San Francisco District Office

Adulteration, CGMP Violations, Contamination

HIGH

TreyMed, Inc.

August 21, 2017 · FDA

Regulatory Violations

MODERATE

Innovita, LLC

August 21, 2017 · Denver District Office

Unapproved Drug Claims, Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Carlton's Dunwoody Pharmacy Corp

August 20, 2017 · Dallas District Office

Misbranding, Adulteration, CGMP Violations, Labeling Violations

MODERATE

Nutrex Research, Inc.

August 18, 2017 · FDA

Labeling Violations

MODERATE

Interquim S.A.

August 17, 2017 · FDA

CGMP Violations

MODERATE

Suisan Company, Ltd

August 17, 2017 · FDA

Regulatory Violations

MODERATE

Corden Pharma Latina S.p.A.

August 17, 2017 · FDA

CGMP Violations

MODERATE

Distribuidora La Jugosita, Inc.

August 17, 2017 · San Juan District Office

Regulatory Violations

MODERATE

Total Nutrition Inc

August 16, 2017 · New York District Office

Labeling Violations

HIGH

Hetero Labs Limited Unit V

August 15, 2017 · Center for Drug Evaluation and Research

Adulteration, CGMP Violations

MODERATE

Applied Medical Resources Corp

August 15, 2017 · FDA

Regulatory Violations

MODERATE

First Medical Source LLC

August 15, 2017 · FDA

Regulatory Violations

MODERATE

O. Scott Wayment Dairy, Inc.

August 15, 2017 · FDA

Regulatory Violations

MODERATE

Service First Pharmacies Inc, dba Madison Drugs

August 14, 2017 · FDA

Regulatory Violations

MODERATE

Bicooya Cosmetics Limited

August 11, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Tianjin Hanaco Xingda Medical Co., Ltd.

August 11, 2017 · FDA

Regulatory Violations

MODERATE

Skin 2 Spirit

August 10, 2017 · Baltimore District Office

Labeling Violations

MODERATE

RESPONSE LETTER

August 10, 2017 · FDA

Regulatory Violations

MODERATE

Nora Apothecary Pharmacy

August 10, 2017 · FDA

Regulatory Violations

MODERATE

C K Solutions, Inc.

August 10, 2017 · Denver District Office

Labeling Violations

MODERATE

Thaveevong Industry Co., Ltd

August 09, 2017 · FDA

Regulatory Violations

MODERATE

Wilbo S.A.

August 08, 2017 · Center for Food Safety and Applied Nutrition

Adulteration, CGMP Violations, Hidden Ingredients

CRITICAL

Flavour Makers Pty Ltd

August 03, 2017 · FDA

Regulatory Violations

MODERATE

Ridley Block Operations Inc

August 03, 2017 · Cincinnati District Office

Adulteration, CGMP Violations

MODERATE

Coleman Peanut Company

August 02, 2017 · Baltimore District Office

Labeling Violations

MODERATE

86 Harriet Ave Corporation DBA General Devices

August 02, 2017 · FDA

Regulatory Violations

MODERATE

Armada Nutrition

August 01, 2017 · Cincinnati District Office

Regulatory Violations

MODERATE

Loreal Usa

August 01, 2017 · FDA

Labeling Violations

MODERATE

DNA Genotek Inc.

August 01, 2017 · FDA

Regulatory Violations

MODERATE

Grant's Smokehouse Ltd.

August 01, 2017 · FDA

Regulatory Violations

MODERATE

HONG NGOC PTE

August 01, 2017 · FDA

Regulatory Violations

MODERATE

D & N Foods Processing Co., LTD.

August 01, 2017 · FDA

Regulatory Violations

MODERATE

Foshan Flying Medical Products Co., Ltd.

August 01, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

RESPONSE LETTER

August 01, 2017 · FDA

Labeling Violations

MODERATE

Frontida BioPharm Inc

April 28, 2017 · FDA

Regulatory Violations

MODERATE

The Lord of the Cigar Corporation

April 27, 2017 · Center for Tobacco Products

Regulatory Violations

MODERATE

Exact-Rx Inc

April 27, 2017 · FDA

Regulatory Violations

MODERATE

Vapor-riffic, Inc.

April 27, 2017 · Center for Tobacco Products

Misbranding, Adulteration, Labeling Violations

MODERATE

Mahard Egg Farm, Inc. (Boogie Hill)

April 26, 2017 · Dallas District Office

Adulteration, Contamination

HIGH

Medical Specialties of California

April 25, 2017 · FDA

Labeling Violations

MODERATE

Noven Pharmaceuticals, Inc.

April 21, 2018 · FDA

Regulatory Violations

MODERATE

Jack P. Herick, Inc. dba Glades Drugs

April 21, 2017 · FDA

Regulatory Violations

MODERATE

Naturecom Inc.

April 20, 2017 · Los Angeles District Office

Regulatory Violations

MODERATE

Montana Emu Ranch Company Inc

April 20, 2017 · Seattle District Office

Regulatory Violations

CRITICAL

Sal Pharma

April 20, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Trafon Group, Inc.

April 19, 2017 · FDA

Regulatory Violations

MODERATE

House of Webster, Inc

April 19, 2017 · FDA

Regulatory Violations

MODERATE

Gladys' Seafood, Inc.

April 19, 2017 · FDA

Regulatory Violations

MODERATE

Backwoods Food Mfg Co Inc

April 19, 2017 · FDA

Regulatory Violations

MODERATE

Phase 4 Pharmaceutical LLC

April 18, 2018 · Dallas District Office

Adulteration, CGMP Violations, Labeling Violations

MODERATE

Iron Forged Nutrition

April 18, 2017 · FDA

Labeling Violations

MODERATE

DSEO LLC

April 18, 2017 · FDA

Labeling Violations

MODERATE

Bull Smoke

April 18, 2017 · FDA

Labeling Violations

MODERATE

Zara Vape Ltd

April 18, 2017 · FDA

Labeling Violations

MODERATE

Tofu Yu, LLC

April 17, 2017 · FDA

Regulatory Violations

MODERATE

Sunstone, Inc.

April 17, 2017 · Denver District Office

Regulatory Violations

CRITICAL

BioStar Technology International, LLC

April 17, 2017 · Los Angeles District Office

Regulatory Violations

CRITICAL

Lifevantage Corp

April 17, 2017 · Denver District Office

Regulatory Violations

CRITICAL

The Vitamin C Foundation

April 17, 2017 · Chicago District Office

Regulatory Violations

CRITICAL

Oxygen Health Systems, LLC

April 17, 2017 · Chicago District Office

Regulatory Violations

CRITICAL

Genetic Edge Compounds LLC

April 14, 2017 · Dallas District Office

Regulatory Violations

HIGH

Starkist

April 14, 2017 · FDA

Regulatory Violations

MODERATE

Caudill Seed & Warehouse Inc

April 14, 2017 · Cincinnati District Office

Regulatory Violations

CRITICAL

Divi's Laboratories Ltd. (Unit II)

April 13, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Magic Juice Shop

April 13, 2017 · FDA

Labeling Violations

MODERATE

Rize Vapor

April 13, 2017 · FDA

Labeling Violations

MODERATE

Pirate VapeStore

April 13, 2017 · FDA

Labeling Violations

MODERATE

KommonCentz

April 13, 2017 · FDA

Labeling Violations

MODERATE

EcigWEcig

April 13, 2017 · FDA

Labeling Violations

MODERATE

Option Care

April 12, 2018 · FDA

Regulatory Violations

MODERATE

Davidus Cigars, Ltd

April 11, 2017 · FDA

Labeling Violations

MODERATE

Gr8 E Vape

April 11, 2017 · FDA

Labeling Violations

MODERATE

Morris and Green Limited

April 11, 2017 · FDA

Labeling Violations

MODERATE

Old Pueblo Vapor

April 11, 2017 · FDA

Labeling Violations

MODERATE

I Puff Vapor

April 11, 2017 · FDA

Labeling Violations

MODERATE

RESPONSE LETTER

April 11, 2017 · FDA

CGMP Violations

MODERATE

Denttio, Inc.

April 10, 2018 · FDA

Regulatory Violations

MODERATE

Oliverio's Italian Style Peppers, Inc.

April 10, 2017 · FDA

Regulatory Violations

MODERATE

Quality Fisheries dba The Niota Fish Market

April 10, 2017 · Chicago District Office

CGMP Violations, Labeling Violations

MODERATE

Shima Laboratories Co., Ltd.

April 06, 2017 · FDA

Regulatory Violations

MODERATE

Amico Beds Corporation

April 06, 2017 · FDA

Regulatory Violations

MODERATE

APS BioGroup, Inc

April 05, 2018 · FDA

Regulatory Violations

MODERATE

Merges, Brian J

April 05, 2018 · FDA

Regulatory Violations

MODERATE

Eco Safe Ecig

April 05, 2017 · FDA

Labeling Violations

MODERATE

RiverMist Vapor

April 05, 2017 · FDA

Labeling Violations

MODERATE

Michael Todd Beauty LP

April 05, 2017 · FDA

Regulatory Violations

MODERATE

OK Smokey Ltd.

April 05, 2017 · FDA

Labeling Violations

MODERATE

Fabrica Confecciones Soto, Inc.

April 05, 2017 · FDA

Regulatory Violations

MODERATE

Jus Bar LLC

April 05, 2017 · New York District Office

Regulatory Violations

CRITICAL

Stix and Stones, Inc.

April 05, 2017 · FDA

Labeling Violations

MODERATE

Pure Smoke LLC

April 05, 2017 · FDA

Labeling Violations

MODERATE

Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center

April 04, 2018 · Los Angeles District Office

Regulatory Violations

MODERATE

Genomyx LLC

April 04, 2017 · FDA

Labeling Violations

MODERATE

Lecheek Nutrition

April 04, 2017 · FDA

Labeling Violations

MODERATE

Abbott's Compounding Pharmacy, Inc.

April 04, 2017 · San Francisco District Office

Regulatory Violations

MODERATE

MS Fruit & Vegetable Co., LLC

April 03, 2018 · FDA

Regulatory Violations

MODERATE

Mylan Laboratories Limited, (Nashik FDF)

April 03, 2017 · Center for Drug Evaluation and Research

CGMP Violations

MODERATE

Vital Pharmaceuticals, Inc. dba VPX Sports

April 03, 2017 · FDA

Labeling Violations

MODERATE

Santos Agency Inc.

April 02, 2018 · FDA

Regulatory Violations

MODERATE

Stoney Ridge Farm, LLC

April 02, 2018 · FDA

Regulatory Violations

MODERATE

MEDICAMAT S.A. - Clsoe Out Letter 8/19/14

Date unknown · FDA

Regulatory Violations

MODERATE