FDA 483 - Aomori Olympus Co., Ltd. - November 07, 2025

An FDA inspection of Aomori Olympus Co., Ltd. in Kuroishi, Japan, revealed significant deficiencies in their medical device manufacturing operations. The firm failed to adequately establish corrective and preventive action procedures, leading to unresolved issues with devices like Sphincterotomes and Thunderbeat that caused patient injuries. Additionally, a critical manufacturing process was not validated, and risk analyses were found to be incomplete, indicating systemic quality control failures.