FDA Inspection
U Rhode Island IRBU Rhode Island IRB – FDA Inspection, Nov 3, 2009
Record Details
This FDA Inspection record concerns U Rhode Island IRB, with an inspection on November 3, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- U Rhode Island IRB
- Inspection Date
- November 3, 2009
- Product Type
- Drugs
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ID · 00d6ba45-a128-4a15-9df9-ec87b5e2a87d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 627147
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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Other FDA inspections of U Rhode Island IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 1, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for U Rhode Island IRB
- FDA Inspection 1054450 - 2018-05-21
- FDA Inspection 875725 - 2014-05-01
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