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

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.