Missing Tests and Altered Records: FDA Warns Chinese OTC Manufacturer

On 12 March 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese drug manufacturing facility, following an inspection in September 2024.

The agency identified serious violations of current Good Manufacturing Practice (CGMP) related to the company's over-the-counter (OTC) drug products.

Key issues included:

• Failure to test identity and quality of incoming raw materials: The firm relied solely on suppliers’ certificates of analysis (COAs) without performing required identity tests.
• Lack of supplier qualification: No formal vendor qualification program existed.
• Lack of testing for high-risk components: Despite prior commitments, identity and impurity testing (e.g., for potential toxic contaminants) was not performed.
• Quality Unit oversight: The Quality Unit failed to enforce product testing, stability programs, and personnel qualification.
• Data integrity violations: Laboratory records lacked complete and original data to support the analyses performed. The use of correction fluid, missing original records, and inconsistent documentation undermined data authenticity. The FDA concluded that the reliability of analytical results was fundamentally compromised.

The FDA demanded a detailed remediation plan, including:

• Retrospective testing of high-risk components and drug products.
• Full qualification of suppliers and revalidation of analytical methods.
• Comprehensive data integrity audits by an independent third party.
• A global corrective and preventive action (CAPA) plan addressing documentation practices, lab procedures, and training.
• Potential appointment of a Chief Integrity Officer to handle whistleblower reports.

Due to these violations, the firm was placed on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs") in January 2025.

For further information, please see the complete Warning Letter to Yangzhou Sion Commodity Co., Ltd. on the FDA's website.