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FDA Slaps Olympus With Another Endoscope Warning

 
• By Brian Bossetta

The US FDA recently rebuked Tokyo-based medical device firm Olympus for failing to adhere to good manufacturing practices for its endoscopes and for not investigating complaints related to the devices.

Fix It!
• Source: Shutterstock

After an inspection of its Tokyo facility in November, the US Food and Drug Administration issued a pointed warning letter to Olympus Medical Systems concerning various single-use endoscopes and related accessories that the company manufacturers there.

The FDA’s letter, issued to Olympus on 17 March, accuses Olympus of producing “adulterated” devices, which means the company did...

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