FDA Inspection
AtlantiCare Regional Medical Center IRBAtlantiCare Regional Medical Center IRB – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns AtlantiCare Regional Medical Center IRB, with an inspection on February 10, 2023, covering drugs.
- Inspection Date
- February 10, 2023
- Product Type
- Drugs
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ID · eac73e3b-a2c5-4e01-ae70-60f82a74244b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196982
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.110(b)(1)No more than minimal risk
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.110(b)(1)No more than minimal risk
- 21 CFR 56.115(a)(3)Records of continuing review
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Other FDA inspections of AtlantiCare Regional Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 29, 2011 | NAI | Bioresearch Monitoring |
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