FDA 483 - Mayo Clinic PET Radiochemistry Facility - September 24, 2025

An FDA inspection of Mayo Clinic PET Radiochemistry Facility in Rochester, MN, revealed significant deficiencies in production and process controls for sterile PET drug manufacturing. These issues include inadequate microbiological testing media controls, failures in sterile filter integrity testing, insufficient environmental monitoring, and poor cleaning and disinfection practices in critical aseptic areas. The findings indicate a high risk of microbial contamination, potentially compromising the quality and purity of sterile PET drug products.