FDA Inspection
Mount Carmel Health System IRBMount Carmel Health System IRB – FDA Inspection, Oct 29, 2019
Record Details
This FDA Inspection record concerns Mount Carmel Health System IRB, with an inspection on October 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 29, 2019
- Product Type
- Drugs
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ID · 7137a6c9-4393-4dd9-90b1-b0a83bf56c46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109631
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.110(b)(2)Minor changes
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Other FDA inspections of Mount Carmel Health System IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Mount Carmel Health System IRB
- FDA Inspection 826531 - 2013-04-16
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