FDA Inspection
Henry Ford Health System Institutional Review BoardHenry Ford Health System Institutional Review Board – FDA Inspection, Nov 10, 2008
Record Details
This FDA Inspection record concerns Henry Ford Health System Institutional Review Board, with an inspection on November 10, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 10, 2008
- Product Type
- Biologics
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ID · b5126980-ad29-4537-b2b7-dd223c924648
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 551112
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.7(a)Promotion of Investigational Drug
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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Other FDA inspections of Henry Ford Health System Institutional Review Board
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2023 | NAI | Bioresearch Monitoring | |
| September 6, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 15, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Henry Ford Health System Institutional Review Board
- FDA Inspection 1225070 - 2023-11-20
- FDA Inspection 1071460 - 2018-09-06
- FDA Inspection 831822 - 2013-05-15
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