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FDA Issues Back-To-Back Warnings To Major Endoscope Maker Amid Device Reporting And Quality Systems Concerns

 
• By Brian Bossetta

The US Food and Drug Administration issued warning letters in 2022 to Japanese device maker Olympus Medical Systems Corporation and a subsidiary concerning good manufacturing practices related to its endoscopes.

You've Been Warned
• Source: Shutterstock

In the closing months of last year, the Food and Drug Administration sent warning letters to Olympus Medical Systems Corporation and its subsidiary Aizu Olympus over violations concerning medical device reporting (MDR) requirements and quality systems regulations for endoscopes and some endoscope accessories.

A 10 January post attributed to Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) states that the warning letters are the most recent in...

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