FDA Warning Letter Highlights Analytical Deficiencies: Lack of Release Testing and Unsupported Expiry Dates

In a Warning Letter dated 24 March 2025 and published on 03 June 2025, the U.S. Food and Drug Administration (FDA) criticizes major analytical GMP violations observed during an inspection in August 2024 at a Chinese drug manufacturing facility.

Key issues include:

• Lack of release testing: Drug batches were distributed to the U.S. market without testing for identity and strength of active ingredients.
• Unsupported expiry dates: Stability data was based on domestic formulations that differed from those intended for the U.S. market. As a result, the data was not representative of U.S. products.

The FDA demands:

• A full specification list and testing plan for all distributed batches
• Re-testing of retain samples still within expiry
• A remediated stability program, including validated, stability-indicating methods
• A CAPA plan addressing test method verification and long-term compliance
• Involvement of a qualified GMP consultant to oversee remediation efforts

The full Warning Letter, issued to Huangshi Hygienic Material Medicine Co., Ltd., is available on the FDA's website.