FDA Inspection
Ascension Sacred Heart Hospital IRBAscension Sacred Heart Hospital IRB – FDA Inspection, Aug 10, 2022
Record Details
This FDA Inspection record concerns Ascension Sacred Heart Hospital IRB, with an inspection on August 10, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 10, 2022
- Product Type
- Devices
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ID · 899dd9b5-7dfd-4d10-961e-8ee6b3cf0a12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1177253
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.115(b)Retention of records
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Other FDA inspections of Ascension Sacred Heart Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 11, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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