FDA EIR - Novartis Pharmaceuticals Corporation - September 07, 2017

An FDA inspection of Novartis Pharmaceuticals Corp.'s East Hanover, NJ facility was conducted from August 28 to September 7, 2017. The inspection, initiated by the Division of New Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance, focused on compliance with Good Laboratory Practice (GLP) for non-clinical drug studies. This unannounced inspection followed a previous GLP inspection in 2014, which resulted in "No Action Indicated." During the current review, the inspectors assessed various aspects, including the firm's transition from active GLP animal testing to maintaining primarily GLP archives and analytical equipment. The inspection covered the firm's training program, Institutional Animal Care and Use Committee (IACUC) procedures, records retention, and audited three non-clinical GLP studies involving rats, dogs, and monkeys. Notably, no deficiencies or violations were identified, and a Form FDA-483 (Inspectional Observations) was not issued. In a general discussion with management at the closeout meeting, the FDA provided recommendations. These included the importance of maintaining GLP status for equipment containing raw data, ensuring the secure retention and accessibility of all GLP records, slides, and blocks, and verifying accessibility of externally archived documents. Novartis was also advised to maintain a clear method for retrieving past GLP studies for future regulatory reviews and to inform the FDA of any changes to the location of archived GLP materials. The company's Global Head of Preclinical Safety and Toxicology committed to upholding GLP standards for their archive.