FDA 483 - Olympus Corporation of the Americas - January 17, 2020

Olympus Corporation of the Americas in San Jose, CA, was cited for significant deficiencies in its quality system, particularly concerning medical device reporting (MDR) and corrective and preventive actions (CAPA). The inspection revealed failures to submit initial and supplemental MDRs in a timely manner, as well as inadequacies in CAPA procedures, documentation, and employee training for complaint evaluation. These issues indicate a systemic breakdown in ensuring compliance with regulatory reporting and quality management requirements.