FDA warns Japan's Olympus units over testing violations

OLYMPUS

10/01/2023 22:59

Jan 10 (Reuters) - The U.S. Food and Drug Administration
on Monday said it has issued warning letters to manufacturers of
medical scopes used in surgical procedures, citing violations
found during inspections of facilities in Japan.
    Warning letters pertain to a category of devices known as
endoscopes, which allow doctors to see and access the urinary
tract, gastrointestinal tract, and respiratory tract, during
diagnostic and therapeutic procedures. 
    The health regulator released the letters on Monday, which
were sent to units of Japan's Olympus Corp  7733.T  - Olympus
Medical System Corp and Aizu Olympus Co -in December and
November, respectively.
    During recent inspections of the units' facilities in Tokyo
and Fukushima, the agency found that the subsidiaries were not
meeting FDA's requirements for assuring quality and performance
of its devices, such as adequate testing and documentation of
the assembly process. 
    The agency added that Olympus Medical did not develop
medical device reporting procedures as mandated and did not
submit them to the regulator in the required timeframes.
    These warning letters add to a history of the U.S. FDA's
compliance actions against Olympus related to testing and
manufacturing requirements. In 2015, Olympus Medical's
duedonoscopes, used for diagnosing or treating disorders of the
gastrointestinal tract, were among those linked to the then
superbug outbreaks at U.S. hospitals.
     The Japanese medical device maker did not immediately
respond to a Reuters request for comment on what steps it was
taking to meet the agency's requirements.  
 (Reporting by Bhanvi Satija in Bengaluru; Editing by Maju
Samuel)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))