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.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.