FDA Inspection
JFK Health IRBJFK Health IRB – FDA Inspection, Feb 18, 2010
Record Details
This FDA Inspection record concerns JFK Health IRB, with an inspection on February 18, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- JFK Health IRB
- Inspection Date
- February 18, 2010
- Product Type
- Drugs
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ID · 28636629-b90e-4e5d-93dc-7f70698bad49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649613
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of JFK Health IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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