# FDA 483 - Aizu Olympus Co., Ltd. - July 08, 2022

Source: https://www.globalkeysolutions.net/records/483/aizu-olympus-co-ltd/06afe784-7c8d-42ec-aede-cf01d7e5a4f6

> FDA 483 for Aizu Olympus Co., Ltd. on July 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aizu Olympus Co., Ltd.
- Inspection Date: 2022-07-08
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Aizu Olympus Co., Ltd. in Aizuwakamatsu, Japan, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate design and process validation, incomplete device history records, lack of written Medical Device Reporting (MDR) procedures, and inaccurate MDR submissions. The firm also failed to adequately establish procedures for quality audits.

## Related Documents

- [WARNING_LETTER - 2022-07-08](https://www.globalkeysolutions.net/records/warning_letter/aizu-olympus-co-ltd/f75eb2e0-811e-40d2-9ef5-21b8df5b0393)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/aizu-olympus-co-ltd/307a9900-e3b9-4513-9199-9bd23c9947f2

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