FDA Warning Letter for Chinese Manufacturer: Inadequate Testing and Stability Program Deficiencies

On 13 May 2025, the U.S. Food and Drug Administration (FDA) has published a Warning Letter dated 15 April 2025 to a Chinese manufacturer of over-the-counter (OTC) drug products.

The inspection, conducted in August 2024, identified multiple violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals:

• Inadequate Testing of Raw Materials: The firm failed to perform identity testing on each lot of high-risk components, relying solely on supplier certificates of analysis (COAs). Despite previous commitments to perform identity testing, the inspection revealed ongoing deficiencies in testing protocols, posing potential risks of contamination.
• Insufficient Process Controls: The company did not establish robust written procedures to ensure the quality, strength, and purity of drug products throughout the manufacturing process.
• Deficient Stability Testing: The stability program was found to be inadequate, lacking comprehensive chemical and microbiological assessments to support the product's expiration dates. The stability testing procedure only required an organoleptic assessment, which was deemed insufficient to confirm product integrity over the shelf life.
• Quality Unit Oversight Deficiencies: The firm’s quality unit failed to provide adequate oversight of manufacturing processes, testing protocols, and stability studies.

As a consequence of the CGMP violations, the FDA placed the firm on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"). The firm is required to submit a comprehensive corrective action plan within 15 working days, addressing all identified deficiencies and outlining measures to prevent recurrence.

For further information, the full Warning Letter to Shantou S.E.Z. Baojie Industry Co., Ltd. is available on the FDA website.