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FDA Inspection
•CAMC-WVU Charleston Division IRB•August 30, 2017

CAMC-WVU Charleston Division IRB – FDA Inspection, Aug 30, 2017

Record Details

This FDA Inspection record concerns CAMC-WVU Charleston Division IRB, with an inspection on August 30, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
CAMC-WVU Charleston Division IRB
Inspection Date
August 30, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Cynthia A. Harris (Company Rep)
View Company Profile

ID · a56ef918-bfe3-4052-bec4-1f2e2261447d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1024052
FDA center
Human Drugs
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 56.115(a)(2)Minutes of IRB meetings

Full citation text and observation details available on the Dashboard.

Other FDA inspections of CAMC-WVU Charleston Division IRB

2
DateClassificationOfficeProject area
June 10, 2022NAICenter for Devices and Radiological HealthBioresearch Monitoring
February 3, 2011VAIBioresearch Monitoring
Other documents for CAMC-WVU Charleston Division IRB
  • FDA Inspection 1172506 - 2022-06-10
  • FDA Inspection 708051 - 2011-02-03

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