FDA WARNING_LETTER - Hangzhou Linkeweier Daily Chemicals Co., Ltd. - September 17, 2019

The FDA issued a Warning Letter to Hangzhou Linkweier Daily Chemicals Co. Ltd. following a September 11-17, 2019, inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's September 24, 2019, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Failure to conduct appropriate laboratory testing for objectionable microorganisms (21 CFR 211.165(b))**: The firm released OTC drug products without ensuring they were free of objectionable microorganisms and failed to adequately monitor their water system for microbial contamination. Required actions include a comprehensive independent assessment of manufacturing operations for microbiological hazards, a detailed risk assessment for distributed products, provision of all chemical and microbial test methods, appropriate microbiological batch release specifications, testing of reserve samples, and a procedure for water system control and monitoring. 2. **Failure to test components for identity and conformity, and validate supplier test analyses (21 CFR 211.84(d)(1) and (2))**: The firm relied on unqualified supplier Certificates of Analysis (COA) for incoming components, including active ingredients, without adequate testing or validation. Required actions include providing chemical and microbiological quality control specifications for components, describing how each lot will be tested, a summary of COA validation results, a program for qualifying contract testing facilities, and an assessment of laboratory