FDA Inspection
Maimonides Medical Center IRBMaimonides Medical Center IRB – FDA Inspection, Jul 15, 2024
Record Details
This FDA Inspection record concerns Maimonides Medical Center IRB, with an inspection on July 15, 2024, issued by the Center for Drug Evaluation and Research.
- Inspection Date
- July 15, 2024
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ID · f70e8cb6-3b0c-4e93-ba0f-6fd8797d8350
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243790
- FDA center
- Human Drugs
- Project area
- Project Evaluation: Devices
FDA Citations
3- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(c)Method to keep members advised
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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Other FDA inspections of Maimonides Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 5, 2011 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
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