Morhaim Pharmalab, Inc. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 16, 2017
Executive Summary
The FDA issued a warning letter to Morhaim Pharmalab, Inc. on May 16, 2017 citing misbranding, adulteration, cgmp violations. The letter was issued by Florida District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Morhaim Pharmalab, Inc.'s operations or product claims.
Potential Health Risks
Wilsce Santiago de Quiroz, PresidentMorhaim Pharmalab, Inc.6990 NW 82nd AveMiami, FL 33166
Regulatory Context
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 6990 NW 82nd Ave., Miami, FL 33166, from September 26, 2016 through September 30, 2016. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your Vital Procollagen dietary supplement product to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplement has been prepared, packed, or held under conditions that do not meet the CGMP requ
Additionally, our investigators collected and reviewed samples of the labeling of your dietary supplement product during the inspection of your facility. Based on our review, your Vital Procollagen product is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA’s labeling regulations under 21 CFR Part 101. You may find the Act and its implementing regulations through links on FDA’s home page atwww.fda.gov.
The inspection revealed the following significant violations:
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Morhaim Pharmalab, Inc.?
- The FDA issued a warning letter citing misbranding, adulteration related to their products or manufacturing practices.
- Are Morhaim Pharmalab, Inc. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have misbranding that may affect product safety.
- What should I do if I've used Morhaim Pharmalab, Inc. products?
- If you have used products from Morhaim Pharmalab, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter