Luen Wah (HK) Medicine Ltd – FDA Warning Letter, Sep 28, 2017

On April 6, 2018, the FDA issued a Warning Letter to Luen Wah (HK) Medicine Ltd. following an inspection from September 25-28, 2017. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products:** The firm released OTC drug products to the U.S. market without testing for identity, strength of active ingredients, total aerobic microbial count, and objectionable microorganisms (21 CFR 211.165(a) and (b)). The firm's response was inadequate, lacking details on specifications, test methods, comparability studies, and retrospective testing of retained samples. 2. **Failure to test components:** The firm relied solely on unqualified supplier Certificates of Analysis (COA) for incoming active pharmaceutical ingredients (API) and other components, failing to test for identity, purity, strength, and other quality attributes (21 CFR 211.84(d)(1) and (2)). The response was inadequate, lacking a list of components to be tested and details on test methods. 3. **Lack of stability data:** The firm failed to establish a stability program, meaning expiration dates on OTC drug products were not supported by appropriate stability testing (21 CFR 211.137(a