Nucrogene Inc – FDA 483, Jul 27, 2026

An FDA inspection of Nitrogene Inc, a drug manufacturer in Branchburg, NJ, revealed significant deficiencies in their quality system. The firm was cited for inadequate process validation, unvalidated equipment cleaning procedures, insanitary conditions, lack of equipment qualification, compromised data integrity, and insufficient computer system controls. These issues indicate a severe lack of control over critical manufacturing processes and data.