FDA 483 - PETNET Solutions Inc - April 18, 2025

An FDA inspection of PETNET Solutions Inc in Kent, WA, revealed a failure to implement adequate equipment cleaning procedures. Inspectors observed visible residue and corrosion on a light panel and a biohazard waste receptacle within the ISO 5 primary engineering control area and hot cell during Fluorodeoxyglucose (FDG) production. These conditions raise concerns about potential adverse effects on PET drug quality and purity.