FDA 就质量体系发出警告后，Olympus 股价跌至 12 周低点

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Olympus shares hit 12-week low after FDA warning over quality systems

AuthorRoushni Nair

Stock Markets

Published Oct 14, 2026, 12:20 AM

Olympus shares hit 12-week low after FDA warning over quality systems

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Olympus shares hit 12-week low after FDA warning over quality systems

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Image 3: © Reuters

In this article:

7733-12.77%

Investing.com -- Olympus (TYO:7733) shares slumped to a 12-week low on Tuesday after the Japanese medical-device maker disclosed a U.S. Food and Drug Administration warning letter raising concerns about aspects of its quality management system and related processes.

The stock fell 12.92% to 1,770 yen, its lowest level since July 24, compared with a 0.9% rise in the Nikkei index.

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Olympus said the warning letter, dated October 7, followed FDA inspections of facilities in the United States, Japan and Europe in late 2025. The observations primarily concerned elements of the company's quality management system and associated procedures.

The company said it would submit a detailed response within 15 business days of receiving the letter and provide periodic updates until the FDA determines that its corrective actions are adequate.

Chief Executive Bob White said Olympus was treating the regulator's concerns seriously and had been working on corrective and preventive measures since the inspections concluded. The company has also been implementing a multi-year programme to strengthen its global quality systems.

Olympus said customers do not need to take additional action following the warning letter and that its products remain safe and effective when used according to their instructions.

The letter does not restrict the company's ability to manufacture, produce, market or distribute products, require any product recalls, or prevent Olympus from seeking FDA 510(k) clearance for new products.

Olympus Corp.

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Chief Quality Officer Brian Barry said the company remained committed to strengthening its quality management systems and embedding a sustainable quality culture across its operations.

The warning adds regulatory pressure as Olympus works to address concerns identified during inspections across multiple regions. Investors will be watching for further updates on the company's corrective actions and whether the FDA considers its response sufficient.

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Olympus shares hit 12-week low after FDA warning over quality systems

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