Yangzhou Sion Commodity Co., Ltd.

Warning LetterOpen

Mr. Chenguang Xu Owner & CEO Yangzhou Sion Commodity Co., Ltd. No. 168 Longwang Road, Hangji Industrial Park Yangzhou Shi Jiangsu Sheng , 225111 ChinaFEI 3011346498Issued Mar 12, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011346498.

Violations4

Issue DateMar 12, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Yangzhou Sion Commodity Co., Ltd.
Location: Mr. Chenguang Xu Owner & CEO Yangzhou Sion Commodity Co., Ltd. No. 168 Longwang Road, Hangji Industrial Park Yangzhou Shi Jiangsu Sheng , 225111 China
FEI Number: 3011346498
Country: China
Issue Date: March 12, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Yangzhou Sion Commodity Co., Ltd., a Chinese drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceutical products. FDA inspectors found that the company failed to test incoming components for identity, purity, strength, and quality per 21 CFR 211.84(d)(1), and did not establish a vendor qualification program or validate supplier test analyses at appropriate intervals. The firm relied on supplier certificates of analysis without conducting independent identity testing on incoming component lots or verifying supplier reliability through validation studies.

Yangzhou Sion Commodity Co., Ltd. FDA Warning Letter, March 12, 2025