Devices

FDA Posts Olympus Letter on Multiple Violations at 6 Sites

David McFarland

— 3 min read
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FDA has posted the Olympus Warning Letter that the company disclosed last week (see story) based on GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025.

According to the letter, FDA inspections at six Olympus Medical Systems manufacturing sites, three in Japan, one in Hamburg, Germany, and one in Brooklyn Park, MN, found multiple violations in the firm’s manufacturing of a variety of surgical and endotherapy medical devices. The 19-page Warning Letter says the specific violations were:

  • failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions;
  • failure to establish and maintain procedures to control product that does not conform to specified requirements;
  • failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure;
  • failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met’
  • failure to ensure that when changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate;
  • failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality problems;
  • failure to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
  • failure to analyze processes, work operations, concessions, quality audit reports, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems;
  • failure to establish and maintain procedures for acceptance of incoming product;
  • failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  • failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications; and
  • failure to report the information required by law and regulations no later than 30 days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device that Olympus markets malfunctioned and that device or a similar device that the firm markets would be likely to cause or contribute to a death or serious injury.

"We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor,” Olympus president and CEO Bob White said recently. “Since the inspections concluded in late 2025, we have worked diligently to implement comprehensive corrective and preventive actions. I am confident in the strength of our team and in our commitment to completing remaining deliverables.” 

Over the past several years, Olympus has executed a comprehensive, multi-year quality system transformation program designed to strengthen its global operations. Olympus says it will submit a comprehensive response to the Warning Letter within 15 business days of receipt and supplement it with periodic updates until the FDA determines that the company’s actions are adequate. 

FDA issued Olympus Medical Systems a Warning Letter after inspecting the firm’s Tokyo facility and documenting GMP deficiencies in 2023. According to the letter, an 11/2022 inspection cited Olympus for failing to adequately establish and maintain procedures for implementing corrective and preventive actions. It also failed to ensure that when changes or process deviations occur, they should be reviewed and evaluated or revalidated where appropriate.

Earlier in 2023, additional inspections at two Olympus medical device manufacturing facilities also in Japan led to separate Warning Letters (see earlier story). At the time, then-CDRH director Jeff Shuren noted in a statement that the two Warning Letters are the “most recent in the history of CDRH’s compliance actions against Olympus related to MDR and quality system requirements. CDRH had been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes.

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