FDA 483 - Jiangsu Anbison Pharmaceutical Co., Ltd. - July 16, 2024

An FDA inspection conducted from July 8 to July 16, 2024, at an unnamed pharmaceutical firm, identified critical manufacturing quality system deficiencies. The inspection highlighted three main observations. First, the firm's quality control unit failed to follow its own procedures, specifically by not reviewing audit trails for High-Performance Liquid Chromatography (HPLC) software used in product analysis. Analysts reportedly made numerous unreviewed changes, like aborted injections, without proper oversight or explanation. Corresponding Standard Operating Procedures lacked provisions for these audit trail reviews, indicating significant data integrity vulnerabilities. Second, validation of aseptic processes for sterile drug products was found inadequate. Media fills, designed to validate sterile manufacturing, did not represent routine production batch sizes. Consequently, the process has not been adequately proven to prevent microbiological contamination during actual drug production. Third, deficiencies were noted in environmental monitoring within aseptic processing areas. The control of non-viable particles generated by specific equipment in a Grade C environment during manufacturing was not adequately established or demonstrated, raising concerns about maintaining required air cleanliness. These findings indicate the firm must promptly address these lapses in quality control, aseptic process validation, and environmental monitoring to ensure compliance with manufacturing regulations and protect product quality and patient safety. The firm is expected to develop and implement comprehensive corrective actions.