# FDA 483 - Olympus Corporation of the Americas - December 16, 2025

Source: https://www.keypedia.com/records/483/olympus-corporation-of-the-americas/0365e92c-cf2f-4dfa-94e2-db3a584bdca9

> FDA 483 for Olympus Corporation of the Americas on December 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olympus Corporation of the Americas
- Inspection Date: 2025-12-16
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Olympus Corporation of the Americas in Center Valley, PA, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to timely report numerous medical device malfunctions to the FDA, maintained inadequate complaint handling procedures, and had prolonged open corrective and preventive actions. Additionally, training procedures for determining medical device reportability were found to be insufficient.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/olympus-corporation-of-the-americas/82bfa101-8376-4c28-a6c9-9fab2c4265d8

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8