Olympus Medical Systems Corp. and one of its subsidiaries, Aizu Olympus Co., were issued two warning letters by the FDA's Center for Devices and Radiological Health following facility inspections.
The warning letters state that there were violations regarding medical device reporting requirements and quality system regulations for endoscopes and endoscope accessories, according to a Jan. 10 news release from the FDA.
The CDRH has been involved in Olympus' efforts to address compliance issues regarding the reprocessing of endoscopes. However, during recent inspections, the CDRH concluded that Olympus did not meet requirements to assure the quality and performance of the devices.
Olympus also failed to develop medical device reporting procedures and did not submit them within the required timeframes, according to the release.
The CDRH is continuing to work with Olympus to ensure the company addresses the violations in the warning letters.