FDA Inspection
Albert Einstein College of Medicine IRBAlbert Einstein College of Medicine IRB – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns Albert Einstein College of Medicine IRB, with an inspection on December 13, 2018, covering drugs.
- Inspection Date
- December 13, 2018
- Product Type
- Drugs
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ID · ef002444-3197-4eee-9f21-6414be216267
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074279
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Albert Einstein College of Medicine IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 31, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 20, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Albert Einstein College of Medicine IRB
- FDA Inspection 1225453 - 2023-11-20
- FDA Inspection 984417 - 2016-08-31
- FDA Inspection 704908 - 2011-01-20
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