TSDR Pharmacy Inc. dba brandMD Skin Care FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on November 09, 2017
Executive Summary
The FDA issued a warning letter to TSDR Pharmacy Inc. dba brandMD Skin Care on November 09, 2017 citing labeling violations. The letter was issued by Los Angeles District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in TSDR Pharmacy Inc. dba brandMD Skin Care's operations or product claims.
Potential Health Risks
Division of Pharmaceutical Quality Operations IV19701 Fairchild, Irvine, CA 92612-2506Telephone: 949-608-2900Fax: 949-608-4417
Regulatory Context
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment [21 CFR 211.67(b)].
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)].
Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products [21 CFR 211.22(a)].
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with TSDR Pharmacy Inc. dba brandMD Skin Care?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are TSDR Pharmacy Inc. dba brandMD Skin Care products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
- What should I do if I've used TSDR Pharmacy Inc. dba brandMD Skin Care products?
- If you have used products from TSDR Pharmacy Inc. dba brandMD Skin Care 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