483
Zhejiang Poly Pharm. Co., LtdFDA 483 - Zhejiang Poly Pharm. Co., Ltd - November 08, 2024
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Zhejiang Poly Pharm. Co., Ltd, a drug product manufacturer in Linping, China, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production and process controls, failure to validate processes for US-bound products, and inadequate equipment cleaning and data integrity controls. These issues indicate a serious lack of adherence to cGMP regulations.
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ID · 86640f55-e86a-43c3-a38a-48b971745ed9