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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.

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• 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 not follow good manufacturing practices as required by the Quality...

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