FDA Inspection
WakeMed IRBWakeMed IRB – FDA Inspection, Apr 29, 2024
Record Details
This FDA Inspection record concerns WakeMed IRB, with an inspection on April 29, 2024, issued by the Center for Biologics Evaluation and Research.
- Company
- WakeMed IRB
- Inspection Date
- April 29, 2024
View Company Profile
ID · a55779bb-5b07-41ce-8a45-d9ef3fec5249
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237142
- FDA center
- Biologics
- Project area
- Project Evaluation: Devices
FDA Citations
3- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
Full citation text and observation details available on the Dashboard.
Other FDA inspections of WakeMed IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 6, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for WakeMed IRB
- FDA Inspection 993732 - 2016-12-08
- FDA Inspection 784930 - 2012-06-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.