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FDA Inspection
•VA Tennesee Valley Healthcare System IRB•May 1, 2012

VA Tennesee Valley Healthcare System IRB – FDA Inspection, May 1, 2012

Record Details

This FDA Inspection record concerns VA Tennesee Valley Healthcare System IRB, with an inspection on May 1, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
VA Tennesee Valley Healthcare System IRB
Inspection Date
May 1, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6ae345ee-c0b8-443c-bef0-10f152ccef47

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
767769
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

5
  1. 21 CFR 56.115(a)(5)List of members
  2. 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
  3. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  4. 21 CFR 56.107(e)Conflict of interest
  5. 21 CFR 56.110(c)Method to keep members advised

Full citation text and observation details available on the Dashboard.

Other FDA inspections of VA Tennesee Valley Healthcare System IRB

1
DateClassificationOfficeProject area
October 26, 2017NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for VA Tennesee Valley Healthcare System IRB
  • FDA Inspection 1035564 - 2017-10-26

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