FDA WARNING_LETTER - Huangshi Hygienic Material Medicine Co., Ltd. - August 30, 2024

The FDA inspected Huangshi Hygienic Material Medicine Co., Ltd. in China from August 26 to 30, 2024, and found significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm failed to perform appropriate laboratory determination of satisfactory conformance to final specifications, including identity and strength of active ingredients, prior to releasing drug products (21 CFR 211.165(a)). Management admitted that identity and strength testing had not been performed for numerous batches for the U.S. market, relying instead on domestic standards that do not require such testing. Additionally, the firm failed to assure that drug products bore an expiration date supported by appropriate stability testing (21 CFR 211.137(a)), assigning U.S. marketed product expiration dates based on domestic product stability despite differing formulations. The FDA deemed the firm's responses inadequate and recommended engaging a qualified CGMP consultant to evaluate operations and conduct a comprehensive six-system audit. Failure to address these violations promptly may result in the FDA withholding approval of new applications, re-inspection, and refusal of admission of articles into the United States under section 801(a)(3) of the FD&C Act. The firm must respond within 15 working days, detailing corrective actions and recurrence prevention.