FDA Inspection
Hunterdon Medical Ctr IrbHunterdon Medical Ctr Irb – FDA Inspection, Mar 21, 2014
Record Details
This FDA Inspection record concerns Hunterdon Medical Ctr Irb, with an inspection on March 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hunterdon Medical Ctr Irb
- Inspection Date
- March 21, 2014
- Product Type
- Drugs
View Company Profile
ID · 0627065f-2e73-4ab8-a50a-612b53e897ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869784
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 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 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of Hunterdon Medical Ctr Irb
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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