Olympus reported it has received a new warning letter from the FDA, following inspections late last year of six manufacturing facilities across Japan as well as in Europe and the U.S.
According to the company, the October 7 letter takes issue with the company’s responses following violations found in its quality management system and related processes, which had been logged within agency Form 483s in 2025. The letter has not yet been posted to the FDA’s public database.
Olympus said it has already put forward corrective and preventive actions related to the inspections, and that it is currently working with the FDA to submit a response to the letter this month along with plans to submit future periodic updates.
The agency’s warning does not restrict the company’s ability to manufacture, sell or distribute its products, nor does it call for any recalls or new clearances.
“We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor,” President and CEO Bob White said in a statement. “I am confident in the strength of our team and in our commitment to completing remaining deliverables.”
The inspections included endoscope-related production facilities and management locations in Japan, in addition to its Hamburg, Germany subsidiary Olympus Winter & Ibe, and its Minnesota-based minimally invasive toolmaker Gyrus ACMI, which the company acquired in 2008.
In recent years Olympus has received multiple warning letters from the FDA tied to its endoscope production and good manufacturing practices, such as for single-use covers for duodenoscopes and bronchoscope accessories.
The agency elevated its scrutiny in mid-2025, alerting healthcare providers about import alerts for certain Olympus hardware manufactured in Japan, including laparoscopes and automated endoscope reprocessors, among others.
In January, Olympus issued a voluntary recall of certain outdated high-flow insufflation units, pulling three models from the market due to software issues that could cause over-pressure and not deliver alarms. The FDA later placed the recall in its most serious, Class I category, following reports of two injuries and zero recorded deaths.
