FDA Issues Warning Letter to Yangzhou Sion Commodity Co., Ltd.

On March 12, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Yangzhou Sion Commodity Co., Ltd., following an inspection conducted from September 23 to 27, 2024. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals. As a result, the FDA has deemed the company’s drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). ​

Key Non-Conformances Identified

Some of the key non-conformances cited in the warning letter include:

Non-Conformance 1: Failure to Test Incoming Components for Identity and Quality

• Regulatory Citation: 21 CFR 211.84(d)(1) and 211.84(d)(2)​
  
  
• Findings: The firm did not test incoming components used in manufacturing finished over-the-counter (OTC) drug products to determine identity, purity, strength, and quality. Additionally, there was no established vendor qualification program for raw material suppliers. The company relied on suppliers’ certificates of analysis (COAs) without validating their reliability and failed to conduct specific identity tests on each incoming lot of components. ​

Non-Conformance 2: Inadequate Quality Control Unit Oversight

• Regulatory Citation: 21 CFR 211.22​
  
  
• Findings: The Quality Control Unit (QU) failed to perform essential functions, including:
  • Conducting assay testing for the strength of active ingredients in drug products.
    
    
  • Ensuring an adequate stability program to support the claimed expiry for drug products.​
    
    
  • Providing adequate training and experience for personnel involved in production and analysis. ​

Non-Conformance 3: Incomplete Laboratory Records

• Regulatory Citation: 21 CFR 211.194(a)​
  
  
• Findings: Laboratory records lacked complete and original data to support analyses performed. Issues included missing data, discrepancies between original and rewritten records, failure to retain original data supporting component testing, and improper documentation practices such as the use of correction fluid on microbial analysis records.

SEE ALSO: Good Documentation Practices

CAPA Plan Recommendations

To address the identified non-conformances, the following Corrective and Preventive Action (CAPA) plan is recommended:

Non-Conformance 1: Failure to Test Incoming Components for Identity and Quality

• Regulatory Citation: 21 CFR 211.84(d)(1) and 211.84(d)(2)​
• Root Cause Analysis (RCA): The absence of a robust component testing program and reliance on unverified supplier COAs indicate deficiencies in the firm’s quality management system and supplier qualification processes.​
  
  
• Corrective and Preventive Actions (CAPA):
  
  
  • Implement a comprehensive testing protocol for all incoming components, including specific identity tests and verification of purity, strength, and quality.
    
    
  • Establish a rigorous supplier qualification and validation program to ensure the reliability of COAs.​
    
    
  • Train quality assurance personnel on the importance of component testing and supplier qualification.​

RELATED: Supplier Qualification in GMP

Non-Conformance 2: Quality Control Unit Oversight

• Regulatory Citation: 21 CFR 211.22​
  
  
• Root Cause Analysis (RCA): The QU’s failure to perform its duties suggests a lack of authority, resources, and understanding of CGMP requirements.​
  
  
• Corrective and Preventive Actions (CAPA):
  
  
  • Conduct a comprehensive assessment of the QU’s responsibilities and resource needs.​
    
    
  • Develop and implement procedures to ensure thorough oversight of manufacturing operations, including batch reviews and stability programs.​
    
    
  • Provide ongoing CGMP training for QU personnel to enhance competency.​

Non-Conformance 3: Incomplete Laboratory Records

• Regulatory Citation: 21 CFR 211.194(a)​
  
  
• Root Cause Analysis (RCA): Inadequate data management practices and a lack of adherence to documentation protocols have compromised Laboratory data integrity.​
  
  
• Corrective and Preventive Actions (CAPA):
  
  
  • Implement a robust data integrity policy, including accurate and complete record-keeping procedures.​
    
    
  • Train laboratory personnel on proper documentation practices and the importance of data integrity.​
    
    
  • Regularly audit laboratory records to ensure compliance with documentation standards.​

RELATED ARTICLE: Data Integrity and Data Governance

Timeline for Implementation

• Immediate Actions (0-3 Months):
  
  
  • Develop and initiate training programs for staff on CGMP requirements and data integrity.​
    
    
  • Begin testing of all incoming components and establish interim supplier qualification procedures.​
    
    
  • Address documentation deficiencies and implement corrective measures in laboratory practices.​
    
    
• Short-Term Actions (3-6 Months):
  
  
  • Complete the comprehensive assessment of the QU and implement necessary structural or procedural changes.​
    
    
  • Fully establish and validate supplier qualification programs.​
    
    
  • Ensure all laboratory records are complete, accurate, and compliant with regulatory standards.​
    
    
• Long-Term Actions (6-12 Months):
  
  
  • Conduct periodic audits to assess the effectiveness of implemented CAPAs.​
    
    
  • Continuously monitor supplier performance and component quality.​
  • Maintain ongoing training programs to uphold CGMP compliance and data integrity.

Conclusion

FDA’s warning letter to Yangzhou Sion Commodity Co., Ltd. underscores critical lapses in CGMP compliance, particularly in component testing, quality control oversight, and data integrity. It is imperative for the company to implement the recommended CAPA plan within the specified timelines to address these violations, ensure product quality, and safeguard public health.