FDA Inspection
Ascension Sacred Heart Hospital IRBAscension Sacred Heart Hospital IRB – FDA Inspection, Jun 23, 2015
Record Details
This FDA Inspection record concerns Ascension Sacred Heart Hospital IRB, with an inspection on June 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 23, 2015
- Product Type
- Devices
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ID · 8f84db1f-ebba-4a0c-964c-75bc2bd1a92d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932404
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
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Other FDA inspections of Ascension Sacred Heart Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2022 | 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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