FDA 483 - PETNET SOLUTIONS, INC. - September 05, 2025

An FDA inspection of PETNET SOLUTIONS, INC. in Overland Park, KS, a PET drug manufacturer, revealed significant deficiencies in production and process controls. The firm's controls to prevent microbial contamination were found to be inadequate, evidenced by multiple environmental monitoring growth occurrences, including some exceeding action limits, and improper aseptic cleaning procedures. These issues indicate a failure to ensure the consistent production of sterile PET drug products.