FDA Inspection
Wake Forest University Health Sciences RDRCWake Forest University Health Sciences RDRC – FDA Inspection, Jul 17, 2018
Record Details
This FDA Inspection record concerns Wake Forest University Health Sciences RDRC, with an inspection on July 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2e1286c4-3db9-4a4f-96ef-205f867e4d3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059075
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 361.1(f)(2)Label - For research use
- 21 CFR 361.1(f)(9)Label - Name, address manufacturer
- 21 CFR 361.1(f)(5)Label - radioactivity, amount
- 21 CFR 361.1(f)(1)Packaging, labeling - Rx only
- 21 CFR 361.1(f)(11)Label - Parenteral drug, sterile
- 21 CFR 361.1(c)(2)Numerical votes not in the minutes of any RDRC meetings
- 21 CFR 361.1(c)(2)Signatures of RDRC Chairman
- 21 CFR 361.1(c)(2)>50% of members not at RDRC meeting
- 21 CFR 361.1(c)(2)Representation of the required fields of expertise
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Other FDA inspections of Wake Forest University Health Sciences RDRC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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