FDA Inspection
Doctors Hospital IRBDoctors Hospital IRB – FDA Inspection, Apr 7, 2009
Record Details
This FDA Inspection record concerns Doctors Hospital IRB, with an inspection on April 7, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Doctors Hospital IRB
- Inspection Date
- April 7, 2009
- Product Type
- Drugs
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ID · a16cadc7-ca39-4b87-a0a9-9f2882d56d86
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 574958
- 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)(2)Minutes of IRB meetings
- 21 CFR 50.25(b)(6)Number of subjects in study
- 21 CFR 56.111(a)(5)Informed consent documented
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
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Other FDA inspections of Doctors Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Doctors Hospital IRB
- FDA Inspection 631706 - 2009-11-18
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