FDA 483 - Shanghai STA Pharmaceutical Product Co., Ltd. - October 22, 2021

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.