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.
An Olympus representative told Medical Design & Outsourcing that the medtech manufacturer would issue a public response as soon as today.
FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5-8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.
FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical end…