FDA 483 - Aomori Olympus Co., Ltd. - July 14, 2022

Aomori Olympus Co., Ltd., a medical device manufacturer in Kuroishi, Japan, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate corrective and preventive actions, insufficient process validation, and incomplete device history records. Additionally, the firm lacked written medical device reporting procedures and submitted inaccurate manufacturer information on adverse event reports.