# FDA 483 - OU Health - October 28, 2024

Source: https://www.keypedia.com/records/483/ou-health/1b424429-11e9-4cd6-8183-0eda01029d19

> FDA 483 for OU Health on October 28, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OU Health
- Inspection Date: 2024-10-28
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of OU Health, an HCT/Ps manufacturer in Oklahoma City, revealed a significant compliance issue regarding donor eligibility documentation. The firm failed to ensure that HCT/Ps were accompanied by a statement confirming donor eligibility was based on screening and testing results. Specifically, their 'HPC Donor Eligibility / Suitability Summary Record' did not explicitly state that eligibility decisions were derived from a review of screening and testing outcomes.

## Related Officers

- [investigator](https://www.keypedia.com/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.keypedia.com/companies/ou-health/0a6ed5fb-c04d-4f4a-b871-ec96e6d3cbea

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9