FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - December 21, 2018

Novel Laboratories, Inc. d.b.a LUPIN in Somerset, NJ, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations of out-of-specification results, failure to submit field alert reports, and insufficient stability data for drug products. Additionally, the firm lacked proper written procedures for production controls, failed to establish test method accuracy, and did not make required records readily available.