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

OLYMPUS

12/01/2023 12:19

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)
 ((Raghav.Mahobe@thomsonreuters.com;))