Japanese medical devices maker Olympus is heading for its biggest one‑day share price fall in 15 years after the US FDA issued a new warning letter that deepens a long‑running regulatory compliance saga. Shares tumbled as much as 16.7% in Tokyo on Wednesday before settling down 13.2%, on track for the largest single‑day drop since the 2011 accounting scandal. The decline leaves the $12.4bn med‑tech group increasingly vulnerable to takeover approaches from private‑equity firms and industry rivals.
The FDA has raised concerns over Olympus’s manufacturing quality since 2022, resulting in a ban on imports of certain endoscopes to the US. The latest warning rebukes the company’s quality management system after problems were found at six factories inspected in the US, Japan and Europe late last year. CEO Bob White said the company takes the concerns seriously and will submit a comprehensive response within 15 business days.
Analyst Stephen Barker at Jefferies said the letter confirms that Olympus’s quality issues are systemic and that full resolution will likely take years rather than quarters. White has been deploying private‑equity‑style tactics — cutting 2,000 jobs, overhauling regional operations and selling assets — to fend off suitors, but the new regulatory setback extends the turnaround timeline.
Source: Financial Times Companies · Summarized by HeadlinesBriefing