FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - October 19, 2021

Tianjin Asychem Pharmaceuticals Co., Ltd. in TEDA West Tianjin was inspected by the FDA from October 13-19, 2021. The inspection revealed a significant issue regarding the firm's inadequate supplier qualification process for a registered starting material. This deficiency indicates a lack of proper oversight in ensuring the quality and manufacturing practices of their suppliers.