# FDA 483 - Aomori Olympus Co., Ltd. - July 14, 2022

Source: https://www.keypedia.com/records/483/aomori-olympus-co-ltd/a840358e-2af5-492b-8bd7-00fd55dd8dfe

> FDA 483 for Aomori Olympus Co., Ltd. on July 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aomori Olympus Co., Ltd.
- Inspection Date: 2022-07-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Aomori Olympus Co., Ltd., a medical device manufacturer in Kuroishi, Japan, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate corrective and preventive actions, insufficient process validation, and incomplete device history records. Additionally, the firm lacked written medical device reporting procedures and submitted inaccurate manufacturer information on adverse event reports.

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd