FDA Inspection
NYU Langone Health Institutional Review BoardNYU Langone Health Institutional Review Board – FDA Inspection, Jul 22, 2015
Record Details
This FDA Inspection record concerns NYU Langone Health Institutional Review Board, with an inspection on July 22, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 22, 2015
- Product Type
- Drugs
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ID · 0fb1da0c-5e04-4e8a-96c1-625e95b04c44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 936460
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of NYU Langone Health Institutional Review Board
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2023 | Not classified | New York District Office | |
| September 15, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 15, 2011 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for NYU Langone Health Institutional Review Board
- FDA Inspection 1206663 - 2023-04-18
- FDA Inspection 986827 - 2016-09-15
- FDA Inspection 736685 - 2011-07-15
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