Hangzhou Zhongmei Huadong Pharmaceutical Co., LtdAugust 18, 2023

FDA 483 - Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd - August 18, 2023

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Record Details

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd was cited for significant deficiencies during an FDA inspection of its sterile drug manufacturing operations. Observations included inadequate procedures for preventing microbiological contamination during aseptic filling, insufficient validation of the aseptic process, and a deficient quality control unit regarding visual inspection speeds. Additionally, the firm lacked appropriate computer system controls to prevent unauthorized data modification in laboratory systems.

Company: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
Inspection Date: August 18, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Wayne D. Mcgrath

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ID · 17808756-e58b-4c57-a0bc-a7e9d8f336ef