483
Gaoyou Qinyou Biological Technology Co., Ltd.Gaoyou Qinyou Biological Technology Co., Ltd. – FDA 483, Oct 18, 2021
Record Details
During an inspection, Gaoyou Qinyou Biological Technology Co., Ltd., an API manufacturer in Yangzhou, China, was cited for deficiencies in equipment cleaning and maintenance. Inspectors observed a production tank labeled as cleaned that contained rust-like spots and lubricant spills on product contact areas, indicating a failure to follow established cleaning procedures. These findings raise concerns about the firm's adherence to quality standards for its crude heparin sodium products.
- Inspection date
- October 18, 2021
- Product type
- drugs
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ID · 33734718-ded1-40b1-9225-eb17f4322bf4
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