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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.