FDA 483 - PETNET Solutions, Inc. - December 04, 2025

An FDA inspection of PETNET Solutions, Inc. in Sacramento, CA, revealed significant deficiencies in their manufacturing processes for PET drug products. The firm failed to investigate numerous repeat system suitability failures for gas chromatography equipment, raising concerns about the validity of analytical test results. Additionally, the inspection identified inadequate cleaning and sanitization procedures, including issues with operator gowning, documentation of disinfectant contact times, and controls for cleaning agents.