# FDA 483 - Aomori Olympus Co., Ltd. - November 07, 2025

Source: https://www.keypedia.com/records/483/aomori-olympus-co-ltd/29371d6c-fc55-4c12-8a29-b71ee0c5b0c7

> FDA 483 for Aomori Olympus Co., Ltd. on November 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aomori Olympus Co., Ltd.
- Inspection Date: 2025-11-07
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Aomori Olympus Co., Ltd. in Kuroishi, Japan, revealed significant deficiencies in their medical device manufacturing operations. The firm failed to adequately establish corrective and preventive action procedures, leading to unresolved issues with devices like Sphincterotomes and Thunderbeat that caused patient injuries. Additionally, a critical manufacturing process was not validated, and risk analyses were found to be incomplete, indicating systemic quality control failures.

## Related Documents

- [483 - 2022-07-14](https://www.keypedia.com/records/483/aomori-olympus-co-ltd/a840358e-2af5-492b-8bd7-00fd55dd8dfe)

## Related Officers

- [Rebecca E. Dorsey](https://www.keypedia.com/people/rebecca-e-dorsey/a52b659a-4a80-47fd-bc62-516daea4efd7)
- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)
- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/aomori-olympus-co-ltd/0ed7e8a7-97a2-425f-8c57-6d32c40902c4

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8