483
Pucheng Chia Tai Biochemical Co. Ltd. - Putan FactoryPucheng Chia Tai Biochemical Co. Ltd. - Putan Factory – FDA 483, Apr 18, 2025
Record Details
Pucheng Chia Tai Biochemistry Co., Ltd., Putian Factory, an Active Pharmaceutical Ingredient manufacturer, was inspected by the FDA. The inspection revealed significant issues with the Quality Unit's oversight of stability data for APIs, specifically regarding moisture content and risk assessments. Additionally, the firm failed to establish adequate document retention procedures, leading to the loss of critical alarm history.
- Inspection date
- April 18, 2025
- Product type
- drugs
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ID · 5281c87b-c46c-498c-91fd-3a749878917f
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