Mayo Clinic PET Radiochemistry Facility – FDA 483, Jul 31, 2026

During an inspection, the FDA observed that Mayo Clinic PET Radiochemistry Facility in Phoenix, AZ, a PET Manufacturer, failed to establish and follow written quality assurance procedures. The facility's corrective and preventive action (CAPA) system was found inadequate, failing to prevent recurring sterility failures and environmental monitoring out-of-specification results due to a lack of root cause analysis. Additionally, the environmental testing procedure was deficient, potentially leading to falsely negative microbial contamination results.