483
Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., LtdHangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd – FDA 483, Aug 19, 2022
Record Details
During an inspection of Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co. Ltd, an Active Pharmaceutical Ingredient Manufacturer, an observation was made regarding the firm's quality unit procedures. Specifically, the firm failed to follow its own change control SOP by not initiating a change control for a specified test in a finished product validation test method. This indicates a lapse in adherence to established quality management processes.
- Inspection date
- August 19, 2022
- Product type
- drugs
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ID · 8809b5ab-40a0-4f71-96fe-261998feaa8e
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