FDA 483 - PetNet Solutions Inc - August 06, 2025

An FDA inspection of PETNET Solutions, Inc. in Elk Grove Village, IL, a Positron Emission Tomography Drug Manufacturer, revealed two observations related to equipment control and qualification. The firm failed to ensure equipment was suitable for its intended purposes, specifically regarding balances lacking controls for date/time stamps and incubators not undergoing proper performance qualification or periodic re-qualification. These issues could impact the quality and validity of PET drug manufacturing and testing.