FDA WARNING_LETTER - Yangzhou Sion Commodity Co., Ltd. - September 27, 2024

The FDA issued a Warning Letter to Yangzhou Sion Commodity Co., Ltd. following an inspection from September 23-27, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not test incoming components for identity, purity, strength, and quality, nor did they validate supplier test analyses or establish a vendor qualification program. This includes a failure to test high-risk components for (b)(4) contamination, despite previous commitments. 2. **Inadequate Quality Control Unit (QCU) oversight:** The QCU failed to ensure drug products complied with CGMP and met specifications, lacking adequate oversight and testing of each batch. 3. **Incomplete laboratory records:** Laboratory records lacked complete and original data, indicating data integrity issues. The firm acknowledged QA management's lack of CGMP understanding.

The FDA found the firm's October 18, 2024, response inadequate, specifically regarding supplier qualification, high-risk component testing, and comprehensive data integrity remediation. The FDA recommends retaining an independent third-party consultant for data integrity remediation.

As a result, products from Yangzhou Sion Commodity Co., Ltd. were placed on Import Alert 66-40 on January 31, 2025. The firm must promptly correct all violations. Failure to