Novitium Pharma LLC – FDA 483, Jul 22, 2026

An FDA inspection of Novitium Pharma LLC in East Windsor, NJ, a prescription drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate computer system controls allowing unauthorized parameter changes and shared access, as well as equipment not designed to capture critical manufacturing data or ensure proper microbial monitoring. Furthermore, the firm's quality control unit failed to adhere to written procedures, leading to improper data integration and a lack of formal investigations for document corrections.