FDA WARNING_LETTER - Hangzhou Facecare Cosmetics Co., Ltd. - June 22, 2017

The FDA issued a Warning Letter to Hangzhou Facecare Cosmetics Co., Ltd. following a June 19-22, 2017, inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products:** The firm released OTC drug products without adequate acceptance testing for conformance to specifications, including identity and strength (21 CFR 211.165(a)). 2. **Inadequate component testing:** The firm did not adequately test incoming active pharmaceutical ingredients and other components for identity, purity, strength, and quality (21 CFR 211.84(d)(1),(2)). 3. **Unsupported expiration dates:** OTC drug products shipped to the U.S. lacked expiration dates, and no stability data supported their shelf lives (21 CFR 211.137(a)).

The firm's July 12, 2017, response was deemed inadequate, lacking sufficient evidence of corrective actions, including specific test methods, comprehensive test results for products and components, procedures for contract facility oversight, stability data, and a comprehensive CGMP assessment with a CAPA plan.

The FDA strongly recommended engaging a qualified CGMP consultant. The firm, as a contract manufacturer, is responsible for the quality of drugs produced. The FDA placed the firm on Import Alert 66-4