FDA Inspection
Excela Health IRBExcela Health IRB – FDA Inspection, May 24, 2010
Record Details
This FDA Inspection record concerns Excela Health IRB, with an inspection on May 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Excela Health IRB
- Inspection Date
- May 24, 2010
- Product Type
- Drugs
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ID · 28bb9c57-a87d-4004-8375-78a6a8cb5ae2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663233
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 56.115(a)(5)List of members
- 21 CFR 50.24(a)(7)Additional protections of rights and welfare
- 21 CFR 50.24(a)(3)Prospect of direct benefit not determined
- 21 CFR 50.24(a)(1)IRB failed to find/document required conditions
- 21 CFR 50.24(a)(5)Not contacting reps within potential therapeutic window
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Excela Health IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Excela Health IRB
- FDA Inspection 868884 - 2014-03-06
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