Hot Shots Nm, LLC – FDA 483, Aug 9, 2019

An FDA inspection of Hot Shots Nuclear Medicine, a PET drug producer in Davenport, IA, revealed significant deficiencies in equipment maintenance, production area cleanliness, and quality control. Observations included issues with the laminar airflow cabinet, use of non-sterile gloves and wipes, lack of environmental monitoring, and failure to investigate unknown peaks in finished drug products. These findings indicate a need for improved controls to ensure the quality and safety of PET drugs.