PETNET Solutions, Inc. – FDA 483, Oct 17, 2022

An FDA inspection of PETNet Solutions, Inc. in Cincinnati, OH, a PET drug manufacturer, revealed significant deficiencies in their manufacturing processes. Observations included inadequate equipment cleaning procedures, improper handling of sterile components leading to potential contamination, and a lack of established action limits for radiochemical yield in master production records. These issues indicate a need for improved quality control and adherence to good manufacturing practices.