FDA Inspection
Wake Forest University Health Sciences RDRCWake Forest University Health Sciences RDRC – FDA Inspection, Mar 7, 2024
Record Details
This FDA Inspection record concerns Wake Forest University Health Sciences RDRC, with an inspection on March 7, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 670620eb-c593-476c-ac45-57181c01e05e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232094
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 361.1(c)(2)Representation of the required fields of expertise
- 21 CFR 361.1(c)(3)Annual reports not submitted to FDA
- 21 CFR 361.1(c)(3)FDA research proposals not reported +30 subjects
- 21 CFR 361.1(c)(2)RDRC has not kept minutes of its meetings
- 21 CFR 361.1(c)(2)>50% of members not at RDRC meeting
- 21 CFR 361.1(c)(2)Numerical votes not in the minutes of any RDRC meetings
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Other FDA inspections of Wake Forest University Health Sciences RDRC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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