FDA Inspection
Cooper Health System IRBCooper Health System IRB – FDA Inspection, Nov 6, 2009
Record Details
This FDA Inspection record concerns Cooper Health System IRB, with an inspection on November 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cooper Health System IRB
- Inspection Date
- November 6, 2009
- Product Type
- Devices
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ID · 2104739b-0a0d-4a54-b4fb-56ef7f52d632
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 629842
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
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Other FDA inspections of Cooper Health System IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | Not classified | New Jersey District Office | |
| January 16, 2020 | NAI | Bioresearch Monitoring | |
| December 3, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Cooper Health System IRB
- FDA Inspection 1294644 - 2025-12-04
- FDA Inspection 1116967 - 2020-01-16
- FDA Inspection 856475 - 2013-12-03
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