The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.
The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.
“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to MassDevice sister site Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”