483
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. – FDA 483
Record Details
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd, a pharmaceutical manufacturer, was inspected by the FDA from June 10-14, 2019. The inspection revealed significant deficiencies in maintaining written records for evaluating drug product quality standards and incomplete batch production and control records, indicating a lack of adequate process control and documentation. These issues suggest potential risks to drug product quality and consistency.
- Product type
- drugs
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ID · 7abf56ab-62b7-4f30-9caf-408534202ff9
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