FDA Warning Letter: GMP Requirements also applicable to HPLC Analyses for Internal Use

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to GFA Production Xiamen Co., Ltd., a Chinese drug manufacturing facility, for significant CGMP violations discovered during a December 2023 inspection.

The letter, dated June 13, 2024, highlights issues with the company's HPLC testing, including the absence of audit trails, lack of validation reports, and unclear testing purposes. Despite committing to controls like audit trails and electronic signatures, the firm did not explain future use of in-house test results.

Additional findings include:

- Inadequate process validation: Only equipment qualification reports were provided.
- Incomplete cleaning validation studies.
- Insufficient equipment maintenance and alarm monitoring.
- Poor microbiological laboratory methods.

These violations indicate serious lapses in CGMP standards, risking product quality and safety. The FDA placed the firm on Import Alert 66-40, barring product import into the USA. The firm has committed to ceasing production and outsourcing manufacturing.

For details, read the full Warning Letter on the FDA's website.