FDA Inspection
Danville Regional Medical Center IRBDanville Regional Medical Center IRB – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns Danville Regional Medical Center IRB, with an inspection on September 15, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 15, 2011
- Product Type
- Drugs
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ID · ef49ebf9-ec73-47af-a7fc-dc202de7732f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 744433
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
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