FDA Inspection
South Shore Hospital Institutional Review BoardSouth Shore Hospital Institutional Review Board – FDA Inspection, Feb 19, 2009
Record Details
This FDA Inspection record concerns South Shore Hospital Institutional Review Board, with an inspection on February 19, 2009, covering devices.
- Inspection Date
- February 19, 2009
- Product Type
- Devices
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ID · f3103025-f497-4eef-8688-57cb85fdb494
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 569943
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 50.25(b)(6)Number of subjects in study
- 21 CFR 56.109(h)Children as subjects
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of South Shore Hospital Institutional Review Board
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for South Shore Hospital Institutional Review Board
- FDA Inspection 881569 - 2014-06-03
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