FDA 483 - Jiangsu Baozong & Baoda Pharmachem Co., Ltd. - June 21, 2019

Jiangsu Baozong & Baoda Pharmachem Co., Ltd, an API manufacturer in Changjiang Town, Rugao, China, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate cleaning procedures and practices, poorly defined critical processing parameters, and failures in quality unit procedures for stability and validation. Additionally, data integrity issues related to analytical equipment access and missing audit trails, along with inadequate equipment maintenance records and procedures, were noted.