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

Source: https://www.keypedia.com/records/483/olympus-corporation-of-the-americas/983f1353-abe9-4f50-8c9b-f41c1aedda96

> 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: FDA District Office — Philadelphia, Pennsylvania
- Summary: The FDA inspection of Olympus Corporation of the Americas in Center Valley, PA, revealed significant deficiencies in their quality system. The firm failed to timely report numerous medical device malfunctions and exhibited inadequate procedures for complaint handling and corrective and preventive actions. These issues indicate a systemic breakdown in monitoring product safety and compliance with regulatory requirements.

## Related Documents

- [483 - 2025-12-16](https://www.keypedia.com/records/483/olympus-corporation-of-the-americas/0365e92c-cf2f-4dfa-94e2-db3a584bdca9)

## 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/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0