FDA Inspection
Maimonides Medical Center IRBMaimonides Medical Center IRB – FDA Inspection, May 5, 2011
Record Details
This FDA Inspection record concerns Maimonides Medical Center IRB, with an inspection on May 5, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 5, 2011
- Product Type
- Biologics
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ID · 40624481-f292-42d6-9084-bb2ef23faeb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 722706
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
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Other FDA inspections of Maimonides Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2024 | VAI | Center for Drug Evaluation and Research | Project Evaluation: Devices |
| September 16, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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