FDA Inspection
St. Rita's Medical Center IRBSt. Rita's Medical Center IRB – FDA Inspection, Jun 26, 2018
Record Details
This FDA Inspection record concerns St. Rita's Medical Center IRB, with an inspection on June 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d62ddf89-7827-4e57-b28f-c61ef5e2ce43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056932
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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Other FDA inspections of St. Rita's Medical Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for St. Rita's Medical Center IRB
- FDA Inspection 792073 - 2012-07-26
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