Nomax Inc – FDA 483, Dec 2, 2022

Novus, Inc., a sterile drug manufacturer in Saint Louis, MO, was cited for significant deficiencies across its quality system, laboratory controls, and manufacturing processes. Observations included failures to investigate critical incidents, inadequate data integrity and testing procedures, and a lack of proper quality unit oversight. These findings indicate a systemic breakdown in GMP compliance impacting the quality and sterility assurance of its ophthalmic strips and potassium bicarbonate tablets.