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

The FDA issued a Warning Letter to Novel Laboratories, Inc. d.b.a. Lupin, following an inspection from September 10 to November 5, 2020, at their Somerset, New Jersey facility. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated. Key deficiencies include inadequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)), leading to observed drug residue and cross-contamination risks on non-dedicated equipment. The firm also failed to establish adequate written procedures for production and process control (21 CFR 211.100(a)), specifically regarding the inadequate validation of temazepam capsule manufacturing processes after equipment and process changes, resulting in out-of-specification (OOS) content uniformity results. Furthermore, the Quality Control Unit (QU) failed to establish and follow adequate written responsibilities and procedures (21 CFR 211.22(d)), demonstrating insufficient oversight in cleaning validation protocol review and annual product review completion. The FDA noted repeat violations at multiple Lupin sites, indicating inadequate corporate oversight. The company must provide a written response within 15 working days, detailing corrective actions, including testing of reserve samples for cross-contamination, a comprehensive retrospective assessment of cleaning effectiveness, a CAPA plan, improvements to cleaning validation and process validation programs, and a remediation plan for the QU. Failure to address these violations promptly may result in regulatory actions, including seizure, injunction, and withholding of new application approvals or export certificates.