FDA 483 - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.

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.