Novel Laboratories, Inc. d.b.a Lupin Somerset – FDA 483, Oct 10, 2025

Novel Laboratories, Inc. d.b.a Lupin in Somerset, NJ, was inspected regarding its manufacturing operations. The inspection revealed deficiencies in design validation procedures for nasal delivery devices used in combination drug products. Specifically, the firm failed to conduct design validation testing under actual or simulated use conditions and had inadequate risk analysis activities, including issues with clinical subject matter expert involvement and unjustified severity reductions in risk management reports.