FDA Inspection
St Michael's Medical Center IRBSt Michael's Medical Center IRB – FDA Inspection, Feb 15, 2013
Record Details
This FDA Inspection record concerns St Michael's Medical Center IRB, with an inspection on February 15, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 15, 2013
- Product Type
- Drugs
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ID · 692e49a8-a5f8-452c-8e8e-9867198f61b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821674
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
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Other FDA inspections of St Michael's Medical Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St Michael's Medical Center IRB
- FDA Inspection 1022162 - 2017-07-06
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