FDA Inspection
Alamance Regional Medical Center IRBAlamance Regional Medical Center IRB – FDA Inspection, Jun 20, 2013
Record Details
This FDA Inspection record concerns Alamance Regional Medical Center IRB, with an inspection on June 20, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 20, 2013
- Product Type
- Drugs
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ID · 5286c3ac-0dd2-41f9-812b-84131d430046
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836906
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(f)Continuing review
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