FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - November 05, 2020

Novel Laboratories, Inc. d.b.a LUPIN received a Form 483 citing significant deficiencies across its manufacturing and quality control operations. Key issues include widespread failures in equipment cleaning and maintenance, inadequate investigations into out-of-specification results and discrepancies, and a lack of adherence to written procedures for stability testing, cleaning validation, and process controls. The facility also exhibited poor building maintenance, insufficient controls for potent drug contamination, and deficiencies in laboratory instrument calibration and personnel training.