# FDA 483 - The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute - September 06, 2024

Source: https://www.keypedia.com/records/483/the-university-of-utah-dba-cyclotron-radiochemistry-lab-huntsman-cancer-institute/3b551f5a-f667-43e2-a66b-ab4e21e2ae5e

> FDA 483 for The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: The University of Utah DBA Cyclotron Radiochemistry Lab, Huntsman Cancer Institute
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Denver District Office
- Summary: The University of Utah DBA Cyclotron Radiochemistry Lab, a PET Drug Manufacturer in Salt Lake City, UT, was cited for failing to follow its written quality assurance procedures. Specifically, the firm did not perform annual product reviews for Pylarify Injection and did not complete or timely sign off on reviews for FDG Fludeoxyglucose F18 Injection as required by its own SOP. This indicates a significant lapse in maintaining quality system compliance for its radiopharmaceutical drug manufacturing.

## Related Officers

- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Company: https://www.keypedia.com/companies/the-university-of-utah-dba-cyclotron-radiochemistry-lab-huntsman-cancer-institute/511ad79a-9e5e-45b0-ac37-ee2cea9e6bc3

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face