FDA Inspection
Willis-Knighton Health System IRBWillis-Knighton Health System IRB – FDA Inspection, Jan 28, 2016
Record Details
This FDA Inspection record concerns Willis-Knighton Health System IRB, with an inspection on January 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 28, 2016
- Product Type
- Drugs
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ID · bc66ab1a-5a3e-4743-9437-0fbb4faf8dc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955900
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.111(a)(4)Informed consent sought
- 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 Willis-Knighton Health System IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Willis-Knighton Health System IRB
- FDA Inspection 736649 - 2011-07-15
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