FDA 483 - Curium US PET LLC - April 18, 2025

Curium US LLC in Noblesville, Indiana, a drug substance and drug product manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate controls over computer systems and electronic data, insufficient investigations into out-of-specification laboratory results, and failures in aseptic processing procedures to prevent microbiological contamination of sterile drug products. These issues indicate a lack of robust quality control and data integrity practices.