Olympus Receives FDA Warning Letter Covering Six Manufacturing Sites

Olympus Corporation said on October 13 that it has received a warning letter from the US Food and Drug Administration covering six of its manufacturing facilities in Japan, Germany and the United States, following FDA inspections conducted in late 2025.

The letter is dated October 7, 2026, US time, according to the Tokyo-based company's news release. Olympus said the items in the letter "primarily concern aspects of the company's quality management system and related processes."

Six sites named

In a separate notice to investors filed the same day, Olympus said the warning letter "addresses the adequacy of Olympus' comprehensive responses to quality management system and process observations" that the FDA had recorded on Form 483s after inspecting the six facilities in late 2025.

The facilities named by Olympus are Olympus Medical Systems Corporation in Hachioji and Hinode, Japan; Aomori Olympus Co., Ltd. and Shirakawa Olympus Co., Ltd., both in Japan; Olympus Winter & IBE GmbH in Hamburg, Germany; and Gyrus ACMI, Inc. in Brooklyn Park, Minnesota.

The FDA's letter itself was not part of the company's announcement, and the agency's findings in this article are as described by Olympus.

What the company says the letter does not do

According to Olympus, the warning letter does not restrict its ability to produce, market, manufacture or distribute products, does not require the recall of any products, and does not restrict the company from seeking FDA 510(k) clearance for new products. The company said customers do not need to take any additional action as a result of the letter.

In the investor notice, Olympus said that based on information currently available, it "does not anticipate that the Warning Letter will have an impact on its consolidated financial results," and that it would make further disclosures if material developments occur.

"We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor," said Bob White, Olympus's president and chief executive officer, in the release. He said the company has worked to implement corrective and preventive actions since the inspections concluded in late 2025.

Brian Barry, the company's chief quality officer, said in the same release: "We remain committed to our ongoing efforts to strengthen and maintain a sustainable quality management system and quality culture."

Next steps

Olympus said it will submit a comprehensive response to the FDA within 15 business days of receiving the letter and will follow it with periodic updates until the agency determines that the company's actions are adequate. The company described the response as part of a multi-year quality system transformation program it has been running across its global operations.

The FDA says that "When FDA identifies what it believes are significant violation(s) of federal requirement(s)," it notifies the responsible party, and that this notification "is often in the form of a Warning Letter." The agency says it then checks any corrections a company describes in its response to ensure they are adequate.