FDA 483 - Petnet Solutions Inc - April 01, 2021

During an inspection from March 22 to April 1, 2021, PETNET Solutions, Incorporated in Covington, LA, was cited for failing to maintain equipment surfaces to prevent alteration of PET drug quality. The observation detailed deficiencies in cleaning procedures and operator aseptic technique, including improper handling of waste and radioactive sources, which could compromise product integrity.