Devices

Olympus Hit With FDA Warning After Global Inspections

FDA has issued Olympus a 10/7 Warning Letter based on GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025. The items in the Warning Letter primarily concern “aspects of the company’s quality management system and related processes,” according to the company.

"We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor,” said Olympus president and CEO Bob White. “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 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. 

The company says that at this time, customers do not need to take any additional actions as a result of this Warning Letter. Products remain safe and effective when used according to their Instructions for Use

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.

The inspection also found that Olympus failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Additionally, FDA says the inspection revealed that the firm’s Single-Use Distal Cover devices were misbranded because Olympus “failed or refused to furnish material or information respecting the device” that is required by FDA’s Medical Device Reporting (MDR) regulation. Specifically, it failed to implement written MDR procedures. It also failed to submit an MDR report within 30 days after becoming aware of a malfunction.

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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