FDA Inspection
Cleveland Clinic Mercy Hospital IRBCleveland Clinic Mercy Hospital IRB – FDA Inspection, Dec 15, 2008
Record Details
This FDA Inspection record concerns Cleveland Clinic Mercy Hospital IRB, with an inspection on December 15, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 15, 2008
- Product Type
- Drugs
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ID · b1a46be6-0a3d-437f-8750-31344f605669
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 553743
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.108(c)Members present for review
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 56.109(h)Children as subjects
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(b)Research not eligible for expedited review
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Other FDA inspections of Cleveland Clinic Mercy Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 1, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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