Olympus Shares Drop by Most Since 2011 After New FDA Warning

By Kimberley Kao

Olympus shares suffered their biggest one-day drop in nearly 15 years after the U.S. Food and Drug Administration issued a new warning following inspections of some facilities.

Shares of the Japanese medical-device maker fell 13.5% in Tokyo on Wednesday, their steepest decline since late 2011, when the company admitted to an accounting scandal.

The letter, dated Oct. 7, concerns the company's quality management system and related processes based on observations from inspections of facilities in the U.S., Japan and Europe conducted in late 2025, Olympus said Tuesday.

"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, president and chief executive of Olympus.

Olympus doesn't expect the warning to affect its financial results or restrict its production, manufacturing and distribution capabilities. The company plans to respond to the letter within 15 business days of receipt.

"The letter is not entirely unexpected, but it disappoints," Jefferies analysts Stephen Barker and Miyabi Yamakita said. Almost a year had passed since the inspections, which left investors hopeful that the FDA had accepted Olympus's corrective actions, the analysts wrote in a note.

The FDA's previous concerns were centered on three Japanese sites, which received warning letters in 2022-2023, Jefferies noted.

The new letter confirms that Olympus's quality issues are systemic, with a full resolution now likely to take longer, the analysts said.

Citi Research analyst Masahiro Shibano said the letter is "a new source of concern" even though no major earnings impact is expected.

"The current situation--in which Olympus's future course is murky--is set to continue," Shibano said.

Write to Kimberley Kao at kimberley.kao@wsj.com

(END) Dow Jones Newswires

October 14, 2026 07:38 ET (11:38 GMT)