# FDA 483 - Olympus Corporation of the Americas - March 10, 2022

Source: https://www.keypedia.com/records/483/olympus-corporation-of-the-americas/bb2c514d-3f00-460e-9c8c-81b6efb7005b

> FDA 483 for Olympus Corporation of the Americas on March 10, 2022. 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: 2022-03-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Olympus Corporation of the Americas in San Jose, CA, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for medical device reporting, ensure proper employee training on adverse event awareness, and effectively manage corrective and preventive actions. Additionally, issues were noted with complaint handling processes and the validation of software used for complaint management.

## Related Documents

- [WARNING_LETTER - 2015-04-24](https://www.keypedia.com/records/warning_letter/olympus-corporation-of-the-americas/e19045f0-edfc-4981-97ea-ca1786e113e1)
- [483 - 2020-01-17](https://www.keypedia.com/records/483/olympus-corporation-of-the-americas/dfe3b127-7889-4791-ab93-7c6e7799d58f)

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)
- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.keypedia.com/companies/olympus-corporation-of-the-americas/b2a67c6c-b9f4-407d-a8b3-0720c4faab45

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b