FDA Inspection
WCG IRB, IncWCG IRB, Inc – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns WCG IRB, Inc, with an inspection on August 24, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9e5bc35-a688-42f3-a6a8-2a22f61e3582
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063861
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
Full citation text and observation details available on the Dashboard.
Other FDA inspections of WCG IRB, Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2021 | NAI | Bioresearch Monitoring | |
| November 12, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 14, 2013 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| November 9, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 11, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for WCG IRB, Inc
- FDA Inspection 1156516 - 2021-11-05
- FDA Inspection 908369 - 2014-11-12
- FDA Inspection 818286 - 2013-02-14
- FDA Inspection 754491 - 2011-11-09
- FDA Inspection 723222 - 2011-05-11
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