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

The FDA issued a Form 483 to Mayo Clinic PET Radiochemistry Facility in Jacksonville, FL, citing significant deficiencies in contamination control and equipment qualification. The inspection revealed inadequate facilities and a failure to properly evaluate disinfectants for aseptic areas, leading to microbial contamination. Additionally, the firm lacked proper documentation to ensure equipment, specifically a laminar flow hood, was suitable for maintaining sterile conditions.