FDA Inspection
The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer InstituteThe University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute, with an inspection on August 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 30, 2018
- Product Type
- Drugs
- People
- Binh T. Nguyen (FDA Associated Person)
- Margaret E. Walsh (Issuing Officer)
- Scott J. Lewis (FDA Associated Person)
- Zachary A. Bogorad
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ID · c34d1f60-a537-4e09-b791-de7e6e3f5d92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063883
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | VAI | Denver District Office | Drug Quality Assurance |
| December 10, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute
- FDA Inspection 1248787 - 2024-09-06
- FDA Inspection 907144 - 2014-12-10
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