# FDA 483 - CIT Ortho - September 05, 2023

Source: https://www.keypedia.com/records/483/cit-ortho/57557db1-9733-4eab-93b9-3ae676e7e435

> FDA 483 for CIT Ortho on September 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CIT Ortho
- Inspection Date: 2023-09-05
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: CIT Ortho, a medical device manufacturer in Westlake, OH, received two observations during an FDA inspection. The firm's complaint handling procedures were found to be inadequately established, lacking defined priority levels and clear investigation requirements. Additionally, their design change procedures were deficient, as required documentation and impact assessments were not routinely completed or justified.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/cit-ortho/7b882ff6-5a8f-48e4-8f98-64b9b2a43b40

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22