Jiangsu Baozong & Baoda Pharmachem Co., Ltd. – FDA 483, Jun 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.
ID · dd02645d-a2eb-472a-adc0-c5c8acf89e86
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.