TOKYO- Medical device maker Olympus Corporation has acknowledged receipt of a new Warning Letter from the U.S. Food and Drug Administration (FDA).
Olympus is based in Japan, but the company’s North American headquarters have been in Upper Saucon Township, Lehigh County since 2006.
According to the FDA’s website, Warning Letters are issued after inspections identify concerns, “such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.”
In a news release, the company said the letter, dated October 7, follows inspections of facilities in the U.S., Japan and Europe in June of 2025.
The items in the Warning Letter primarily concern “aspects of the company’s quality management system and related processes,” Olympus said, but did not offer specifics.
The letter is not yet available in the FDA database.
“We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor,” said Olympus CEO Bob White, in the release. “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.”
Olympus said it will submit a comprehensive response to the FDA within 15 days.
Of the six facilities inspected by the FDA last June, only one – Brooklyn Park- is in the U.S. Four are in Japan, and one is in Germany.
Olympus said it does not anticipate that the letter will have an impact on its consolidated financial results; its next earnings report is expected in less than a month.
But the company’s shares, which are listed on the Tokyo Stock Exchange, have taken a hit this week.
Shares plunged nearly 14% on Wednesday, which, according to the Financial Times, was their biggest single day drop since the company’s accounting scandal came to light in 2011.