FDA 483 - Ningbo Shuangcheng Pharmaceutical Co., Ltd - November 03, 2023

An FDA inspection of Ningbo Shuangcheng Pharmaceutical Co., Ltd. in Ningbo, China, revealed two significant observations. The firm's quality control unit was found to lack proper responsibility for approving procedures and specifications, particularly concerning change control for document revisions. Additionally, equipment and utensils were not cleaned at appropriate intervals, leading to visible residue on primary packaging equipment.