Olympus says fixing issues raised by U.S. FDA about facilities in Japan

FDA

Olympus says fixing issues raised by U.S. FDA about facilities in Japan

Jan 12 (Reuters) – Olympus Corp (7733.T), a Japanese medical device maker, said it was taking action to address concerns raised by the U.S. health regulator related to violations found during the inspection of the company’s facilities in Japan.

The U.S. Food and Drug Administration (FDA) said on Monday it had issued warning letters to Olympus’ units pertaining to a category of devices known as endoscopes, citing violations at its facilities.

Olympus said it was making changes to the quality systems at its facilities.

Responses to each warning letter have been submitted to FDA, and the actions to fix the issues is progressing, a company spokesperson said in an emailed response late Wednesday.

Reporting by Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters

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