483
Zhejiang Dingtai Pharmaceutical Co., LtdZhejiang Dingtai Pharmaceutical Co., Ltd – FDA 483, Feb 28, 2025
Record Details
An FDA inspection of Zhejiang Dingtai Pharmaceutical Co., Ltd, a manufacturer of OTC drug products, revealed three significant observations. The firm was cited for inadequate laboratory controls, specifically regarding microbiological media preparation and testing, and for insufficient control procedures for manufacturing processes. Additionally, the inspection found a lack of detailed written procedures for the sampling, testing, approval, and rejection of components.
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ID · c42b49e1-6f7e-47c3-96a1-45ba7b7f9267
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