FDA 483 - Jiangsu Anbison Pharmaceutical Co., Ltd. - August 18, 2023

During an inspection that commenced on August 14th, the U.S. Food and Drug Administration (FDA) issued a Form 483 observation to Mnbison Pharmaceutical Co. Ltd., a drug manufacturer based in Taizhou, Jiangsu, China. The primary issue identified was that equipment used in the manufacture, processing, packing, or holding of drug products was not designed appropriately for its intended use. Specifically, two equipment qualifications, VR-PD-2020-2034 and VR-Pp-Pa-2020-2001, were found to lack a sufficient number or robustness of tests. This deficiency raised concerns about the consistency of the manufacturing process and the potential for the drug product's active ingredient to adversely affect critical product attributes, such as potency or purity. The FDA's issuance of a Form 483 indicates potential deviations from current Good Manufacturing Practices (GMP). Mnbison Pharmaceutical Co. Ltd. is expected to evaluate and implement comprehensive corrective actions to address these significant concerns and ensure compliance with regulatory standards for pharmaceutical quality and safety.