FDA Inspection
Rutgers State of NJ IRBRutgers State of NJ IRB – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns Rutgers State of NJ IRB, with an inspection on June 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fc089b01-8f2b-40c5-a441-8d3cc10c9ede
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055581
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 56.108(c)Members present for review
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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Other FDA inspections of Rutgers State of NJ IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2021 | NAI | Bioresearch Monitoring | |
| December 5, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Rutgers State of NJ IRB
- FDA Inspection 1160439 - 2021-12-09
- FDA Inspection 755406 - 2011-12-05
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