FDA 483 - Chia Tai Tianqing Pharmaceutical Group Co., Ltd. - January 06, 2021

An FDA inspection of Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in Lianyungang, China, revealed deficiencies in the firm's quality control unit. The company failed to ensure that responsibilities and procedures for the quality control unit were adequately documented and followed. Specifically, issues were noted with assessing the effectiveness of corrective and preventive actions (CAPA) and with internal audit procedures.