FDA 483 - Olympus Corporation of the Americas - December 16, 2025

An FDA inspection of Olympus Corporation of the Americas in Center Valley, PA, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to timely report numerous medical device malfunctions to the FDA, maintained inadequate complaint handling procedures, and had prolonged open corrective and preventive actions. Additionally, training procedures for determining medical device reportability were found to be insufficient.