FDA Inspection
Jamaica Hospital Medical Center IRBJamaica Hospital Medical Center IRB – FDA Inspection, Aug 20, 2015
Record Details
This FDA Inspection record concerns Jamaica Hospital Medical Center IRB, with an inspection on August 20, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 20, 2015
- Product Type
- Drugs
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ID · 60327bdd-2075-4057-be20-8205afadc825
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 938949
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Jamaica Hospital Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | Not classified | New York District Office | |
| August 22, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Jamaica Hospital Medical Center IRB
- FDA Inspection 1250109 - 2024-09-18
- FDA Inspection 1023570 - 2017-08-22
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