FDA Inspection
SUNY Downstate Health Sciences University IRB & Privacy BoardSUNY Downstate Health Sciences University IRB & Privacy Board – FDA Inspection, May 22, 2015
Record Details
This FDA Inspection record concerns SUNY Downstate Health Sciences University IRB & Privacy Board, with an inspection on May 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 22, 2015
- Product Type
- Devices
View Company Profile
ID · 30c8950e-5511-472e-8229-ed3ea6e10489
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926844
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.115(a)(2)Minutes of IRB meetings
Full citation text and observation details available on the Dashboard.
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 |
| March 26, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 23, 2008 | OAI | 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 655378 - 2010-03-26
- FDA Inspection 539266 - 2008-10-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.