Mayo Clinic PET Radiochemistry Facility – FDA 483, Jul 17, 2026

The FDA issued a Form 483 to Mayo Clinic PET Radiochemistry Facility in Jacksonville, FL, following an inspection of their PET manufacturing operations. The inspection revealed significant deficiencies including inadequate facilities for sterile product dispensing, incomplete master production records leading to omitted critical testing, use of unqualified raw material suppliers, and inaccurate laboratory analytical methods. These observations indicate serious concerns regarding product quality, contamination control, and overall compliance with good manufacturing practices.