FDA Inspection
U Rhode Island IRBU Rhode Island IRB – FDA Inspection, May 1, 2014
Record Details
This FDA Inspection record concerns U Rhode Island IRB, with an inspection on May 1, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- U Rhode Island IRB
- Inspection Date
- May 1, 2014
- Product Type
- Devices
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ID · b84cad16-9243-40dd-92c3-850e1fe14132
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 875725
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 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 |
| November 3, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for U Rhode Island IRB
- FDA Inspection 1054450 - 2018-05-21
- FDA Inspection 627147 - 2009-11-03
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