FDA Flags Serious GMP Violations at Chinese Drug Facility

In a Warning Letter dated March 24, 2025, the FDA cited Huangshi Hygienic Material Medicine Co., Ltd. for major analytical GMP lapses found during an August 2024 inspection. Key violations include releasing drug batches to the U.S. without identity or strength testing and assigning expiry dates based on non-U.S. formulations.

The FDA has ordered the company to submit a full testing plan, re-test retained samples, overhaul its stability program using validated methods, and implement a corrective action plan. A qualified GMP consultant must also be engaged to ensure compliance.

These findings raise serious concerns about product quality and regulatory adherence for U.S. drug imports. The full letter is available on the FDA’s official website.

22-06-2025