Hangzhou Facecare Cosmetics Co., Ltd. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on November 17, 2017
Executive Summary
The FDA issued a warning letter to Hangzhou Facecare Cosmetics Co., Ltd. on November 17, 2017 citing cgmp violations. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Hangzhou Facecare Cosmetics Co., Ltd.'s operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Hangzhou Facecare Cosmetics Co., Ltd..
Regulatory Context
The quality control test methods and specifications used by your firm (or a contract laboratory) to analyze each drug product batch prior to a batch release decision.
A summary of test results obtained from testing all in-date drug products for United States distribution for identity and strength of active ingredients, and all other appropriate quality attributes (including total count and objectionable microorganisms).
A summary of your procedures (e.g., qualification, audit, delineation of responsibilities) for qualifying and overseeing the adequacy of contract facilities that test the drug products you manufacture.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Hangzhou Facecare Cosmetics Co., Ltd.?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Hangzhou Facecare Cosmetics Co., Ltd. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
- What should I do if I've used Hangzhou Facecare Cosmetics Co., Ltd. products?
- If you have used products from Hangzhou Facecare Cosmetics Co., Ltd. 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