FDA Inspection
SUNY Downstate Health Sciences University IRB & Privacy BoardSUNY Downstate Health Sciences University IRB & Privacy Board – FDA Inspection, Oct 23, 2008
Record Details
This FDA Inspection record concerns SUNY Downstate Health Sciences University IRB & Privacy Board, with an inspection on October 23, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 23, 2008
- Product Type
- Drugs
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ID · 3687e830-031b-4106-a47b-c19f55a7f17a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 539266
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of SUNY Downstate Health Sciences University IRB & Privacy Board
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 22, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 26, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for SUNY Downstate Health Sciences University IRB & Privacy Board
- FDA Inspection 1085582 - 2019-03-08
- FDA Inspection 926844 - 2015-05-22
- FDA Inspection 655378 - 2010-03-26
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