483
Olympus Corporation of the AmericasFDA 483 - Olympus Corporation of the Americas - December 16, 2025
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The FDA inspection of Olympus Corporation of the Americas in Center Valley, PA, revealed significant deficiencies in their quality system. The firm failed to timely report numerous medical device malfunctions and exhibited inadequate procedures for complaint handling and corrective and preventive actions. These issues indicate a systemic breakdown in monitoring product safety and compliance with regulatory requirements.
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ID · 983f1353-abe9-4f50-8c9b-f41c1aedda96