# FDA 483 - Mayo Clinic PET Radiochemistry Facility - December 12, 2019

Source: https://www.keypedia.com/records/483/mayo-clinic-pet-radiochemistry-facility/19c71076-c59a-468e-b243-062357bece4c

> FDA 483 for Mayo Clinic PET Radiochemistry Facility on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mayo Clinic PET Radiochemistry Facility
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: Denver District Office
- Summary: The FDA inspected Mayo Clinic PET Radiochemistry Facility in Phoenix, AZ, a PET drug manufacturer, and issued a Form 483 with three observations. The inspection revealed significant deficiencies in production and process controls, including inadequate personnel monitoring and aseptic technique. Additionally, the firm failed to validate non-compendial microbiological testing methods and did not properly implement or document equipment cleaning, maintenance, and qualification procedures.

## Related Officers

- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)
- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

Company: https://www.keypedia.com/companies/mayo-clinic-pet-radiochemistry-facility/6f50594f-958c-4e96-8874-16af21beeedb

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