FDA Inspection
Walter Reed Army Medical Center IRBWalter Reed Army Medical Center IRB – FDA Inspection, Oct 29, 2010
Record Details
This FDA Inspection record concerns Walter Reed Army Medical Center IRB, with an inspection on October 29, 2010, covering drugs.
- Inspection Date
- October 29, 2010
- Product Type
- Drugs
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ID · dc7c09b5-620f-4461-93fe-2fd328fd2c83
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695483
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.107(f)Invited individual allowed to vote with IRB
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