Drug factory · FDA FEI 3004010435
The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute
2000 Circle of Hope, Salt Lake City, UT, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 6, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2014: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 6, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 30, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Dec 10, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 30, 2018 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function. - Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not take appropriate corrective actions when necessary. - Supplies adequately controlled 21 CFR 212.60(d)
Your quality of supplies used in your testing procedures are not adequately controlled.
Registered with FDA for: positron emission tomography drug production.