# FDA 483 - Ascension Sacred Heart Hospital IRB - August 10, 2022

Source: https://www.globalkeysolutions.net/records/483/ascension-sacred-heart-hospital-irb/c6976d27-5183-4d9f-845d-026535967ebc

> FDA 483 for Ascension Sacred Heart Hospital IRB on August 10, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascension Sacred Heart Hospital IRB
- Inspection Date: 2022-08-10
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ascension Sacred Heart Hospital IRB in Pensacola, FL, revealed a significant issue with record maintenance. The Institutional Review Board failed to properly maintain records required by 21 CFR 56, specifically regarding the identification of IRB voting members by name and representative capacity for several years. This indicates a moderate severity finding related to regulatory compliance for IRB operations.

## Related Officers

- [Leon L. Crawley](https://www.globalkeysolutions.net/people/leon-l-crawley/973f0ced-69a4-4adb-9e3c-e088e78a4516)

Company: https://www.globalkeysolutions.net/companies/ascension-sacred-heart-hospital-irb/adb4800f-e377-49d6-a31d-eb80a3d4ccda

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6