FDA EIR - Novartis Pharmaceuticals Corporation - January 24, 2017

An FDA surveillance inspection of Novartis Pharmaceuticals Corp. from January 10-24, 2017, identified significant issues in their conduct of clinical trials. The company failed to notify the FDA about the termination for cause of a clinical investigator in Italy, a crucial step for ensuring good clinical practice (GCP) compliance. Furthermore, Novartis did not retain seven site quality control reports related to a Corrective Action Plan for one study, hindering record completeness. A notable lack of monitoring was observed at one clinical site where a patient had been enrolled and subsequently died, raising concerns about patient safety oversight. The inspection also found widespread non-adherence to monitoring protocols: several sites had delayed monitoring visits, and 32 of 51 sites in another study did not receive timely or annual visits as mandated. Additionally, multiple monitoring reports across both studies lacked required signatures from Clinical Research Associates or second reviewers. These findings highlighted non-compliance with regulatory frameworks including 21 CFR 312.56(b), 21 CFR 312.57(c), 21 CFR 312.56(a), and 21 CFR 312.50. Novartis management committed to providing written responses addressing these observations within 15 days.