FDA 483 - Aizu Olympus Co., Ltd. - July 08, 2022

An FDA inspection of Aizu Olympus Co., Ltd. in Aizuwakamatsu, Japan, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate design and process validation, incomplete device history records, lack of written Medical Device Reporting (MDR) procedures, and inaccurate MDR submissions. The firm also failed to adequately establish procedures for quality audits.