FDA WARNING_LETTER - Chan Yat Hing Medicine Factory - July 08, 2015

On December 15, 2015, the FDA issued a Warning Letter to Chan Yat Hing Medicine Factory following an inspection from July 6-8, 2015, at their Hong Kong facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for finished pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated under Section 501(a)(2)(B) of the FD&C Act.

Key violations included: 1. Failure to test finished drug product batches for identity and strength of active ingredients (21 CFR 211.165(a)). 2. Failure to ensure identity of components, including active ingredients and excipients (21 CFR 211.84(d)(1) and (2)). 3. Lack of data to demonstrate chemical and physical stability throughout the product's shelf life (21 CFR 211.166(a)). 4. Absence of adequate written procedures for production and process controls, including validation (21 CFR 211.100(a)). 5. Failure to establish written responsibilities and procedures for the quality control unit, including handling out-of-specification results and customer complaints (21 CFR 211.22(d)). 6. Failure to calibrate and maintain records