FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - January 13, 2023

Novel Laboratories, Inc. d.b.a Lupin in Somerset, NJ, was inspected and received two observations related to manufacturing practices. The inspection revealed deficiencies in laboratory controls, specifically regarding the scientific justification for microbial testing procedures, and issues with equipment qualification and design for its intended use in drug product manufacturing. These findings indicate potential risks to drug product quality and purity.