The FDA has issued Olympus Corporation a warning letter over issues primarily involving the medical technology company’s quality management system and related processes.
The Oct. 7 letter was based on observations from FDA inspections of Olympus facilities in the U.S., Japan and Europe conducted in late 2025, according to an Oct. 13 news release.
Olympus said it will submit a comprehensive response within 15 business days of receiving the letter and provide periodic updates until the FDA determines its actions are adequate.
Customers do not need to take additional actions because of the warning letter, Olympus said. The letter does not require product recalls or restrict the company’s ability to produce, market, manufacture or distribute products or seek FDA 510(k) clearance for new products.
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