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FDA Inspection
•WCG IRB, Inc•November 9, 2011

WCG IRB, Inc – FDA Inspection, Nov 9, 2011

Record Details

This FDA Inspection record concerns WCG IRB, Inc, with an inspection on November 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
WCG IRB, Inc
Inspection Date
November 9, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 835b92fd-6bdf-49b0-8c69-e4d58dd6de2e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
754491
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
  2. 21 CFR 56.108(a)(1)Initial and continuing reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of WCG IRB, Inc

7
DateClassificationOfficeProject area
November 5, 2021NAIBioresearch Monitoring
August 24, 2018VAICenter for Devices and Radiological HealthProject Evaluation: Devices
November 12, 2014VAICenter for Devices and Radiological HealthBioresearch Monitoring
February 14, 2013NAICenter for Biologics Evaluation and ResearchBioresearch Monitoring
May 11, 2011NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
View all 7 other inspections on the company page
Other documents for WCG IRB, Inc
  • FDA Inspection 1156516 - 2021-11-05
  • FDA Inspection 1063861 - 2018-08-24
  • FDA Inspection 908369 - 2014-11-12
  • FDA Inspection 818286 - 2013-02-14
  • FDA Inspection 723222 - 2011-05-11

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