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, Sep 6, 2024
Record Details
This FDA Inspection record concerns The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute, with an inspection on September 6, 2024, issued by the Denver District Office, covering human drugs.
- Inspection Date
- September 6, 2024
- Product Type
- Human Drugs
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ID · 87a7476f-9e29-47b5-8a53-c3694e660d0e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1248787
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 212.20(e)Written QA procedures established, followed
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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 |
|---|---|---|---|
| August 30, 2018 | VAI | Center for Drug Evaluation and Research | 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 1063883 - 2018-08-30
- FDA Inspection 907144 - 2014-12-10
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