# FDA 483 - Olympus Medical Systems Corp. - November 07, 2022

Source: https://www.globalkeysolutions.net/records/483/olympus-medical-systems-corp/ca84eb42-64a2-4bbd-8077-da2573ceee21

> FDA 483 for Olympus Medical Systems Corp. on November 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olympus Medical Systems Corp.
- Inspection Date: 2022-11-07
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Olympus Medical Systems Corp Hinode Plant identified significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions and complaint handling, leading to unaddressed complaints and inadequate investigations. Additionally, issues were noted with device history records and the re-validation of manufacturing processes after changes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/olympus-medical-systems-corp/c7f28eba-1402-4596-9b34-4d98941492da

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321