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

During an FDA inspection conducted from September 22-24, 2025, the firm was cited for significant deficiencies in its production and process controls for sterile Positron Emission Tomography (PET) drug products. The observations, detailed in an FDA Form 483, indicate a lack of adequate controls to ensure product identity, strength, quality, and purity, as required under the Federal Food, Drug, and Cosmetic Act. Key issues included a failure to establish adequate controls for microbiological testing media, evidenced by 14 unexplained growth promotion failures since October 2024. Sterility testing procedures were also inadequate, with an operator incorrectly performing a crucial integrity test and falsely documenting a "Pass" result. Environmental monitoring for aseptic operations was deficient, lacking post-manipulation checks and improper sequencing of monitoring relative to production. Microbial contamination prevention was compromised by an operator's exposed face entering an ISO 5 cleanroom hood during sterility media inoculation. Furthermore, the firm's established microbial contamination limits for ISO 5 areas were deemed inadequate, and cleaning and disinfection controls were lacking, with observed unidentified particles remaining on surfaces used for sterile product operations. These observations highlight a critical need for the firm to implement comprehensive corrective actions to address these systemic control failures, ensuring the sterile manufacture of its PET drug products and compliance with good manufacturing practices.