FDA Warning Letter to Chinese OTC Manufacturer Highlights CGMP Failures

On May 13, 2025, the FDA issued a Warning Letter (dated April 15) to a Chinese OTC drug manufacturer following an August 2024 inspection. The agency found serious CGMP violations, including failure to perform identity testing on high-risk raw materials, relying solely on supplier certificates despite prior promises to test.

Process controls were weak, lacking proper written procedures to maintain product quality. The stability testing was inadequate, using only organoleptic assessment without necessary chemical or microbiological tests to justify product shelf life.

The firm’s Quality Unit failed to adequately oversee manufacturing, testing, and stability studies. Consequently, the FDA placed the company on Import Alert 66-40, requiring a corrective action plan within 15 working days to address these issues and prevent recurrence.

27-05-2025