Dive Brief:
- Olympus said this week it is making progress on strengthening its quality systems as it addresses issues raised in a series of Food and Drug Administration warning letters. CEO Bob White said in an earnings presentation that since January, the company has intensified remediation and quality improvement efforts to address the agency’s concerns.
- The update comes after the FDA in October delivered a new warning letter to Olympus over quality system regulation violations and issued import alerts to prevent additional endoscope models manufactured in Japan from entering the U.S. The warning letter cited inspections conducted at six facilities in late 2025, in Japan, Europe and the U.S.
- The Tokyo-based medtech company gave the update as it reported its fiscal second-quarter financial results. Ship holds and FDA import alerts disclosed in June 2025 had a roughly 9 billion yen (about $56 million) impact on consolidated revenue, Olympus said.
Dive Insight:
The FDA sent three warning letters to Olympus, a leading endoscope manufacturer, in 2022 and 2023 after inspections at Japanese sites found quality system violations and a failure to meet medical device reporting requirements. Then in June 2025, the FDA blocked 58 endoscope models from entering the U.S. In October, the FDA added five more devices to the list of products denied entry, citing persistent concerns.
The warning letters and import blocks follow investigations by the agency into infections associated with reprocessed duodenoscopes and urological endoscopes dating back a decade.
In a transcript of Olympus’ latest earnings presentation posted on the company’s website, White said Olympus has accelerated its remediation and quality improvement efforts.
“After almost a year of our intensified efforts, new leadership, embedded expertise, we already see strides in addressing the FDA's areas of concern,” said White, a former Medtronic and GE HealthCare executive who joined Olympus as CEO in June 2025.
Over the past year, Olympus has recruited industry experts with experience in quality and operations leadership and increased headcount and depth in FDA regulatory expertise across key areas, White said.
Olympus said it continues to work with the FDA to demonstrate that its corrective actions are effective and sustainable.
The issues raised in the latest FDA warning letter “will ensure that the work we’ve already done is solid and also sharpen our approach going forward to provide the sustained evidence that the agency is expecting,” White said.
Olympus reported a 9% increase in revenue, to 269.2 billion yen ($1.68 billion), in the second quarter of its fiscal year ending March 31, 2027. The company also raised revenue, adjusted operating margin and adjusted earnings per share guidance for the full fiscal year.
