483
Shanghai STA Pharmaceutical Product Co., Ltd.Shanghai STA Pharmaceutical Product Co., Ltd. – FDA 483, Oct 22, 2021
Record Details
Shanghai STA Pharmaceutical Product Co, Ltd, a contract manufacturer in Shanghai, was inspected by the FDA from October 18-22, 2021. The inspection revealed significant deficiencies in record-keeping practices, including a lack of cleaning records and insufficient second-person verification during weighing operations. Additionally, the firm failed to consistently conduct written investigations for quality deviations.
- Inspection date
- October 22, 2021
- Product type
- drugs
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ID · 66f84ae1-1dfe-4c3d-8d89-537b9ac0cad5
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