FDA Inspection
Ascension St. John Hospital IRBAscension St. John Hospital IRB – FDA Inspection, Dec 23, 2016
Record Details
This FDA Inspection record concerns Ascension St. John Hospital IRB, with an inspection on December 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a694c92f-9bb6-49e2-9558-3d0a99c59e55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997372
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 56.107(e)Conflict of interest
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Other FDA inspections of Ascension St. John Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2022 | NAI | Bioresearch Monitoring | |
| March 21, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Ascension St. John Hospital IRB
- FDA Inspection 1178321 - 2022-08-12
- FDA Inspection 776083 - 2012-03-21
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