FDA EIR - Novartis Pharmaceuticals A. G. - March 23, 2017

An FDA inspection of Novartis Pharma A.G.'s Broomfield, CO facility, conducted from March 20-23, 2017, focused on post-marketing adverse drug experience (PADE) reporting under Compliance Program 7353.001. This was the initial PADE inspection for this location, which houses the Pharmacovigilance (PV) Unit for Sandoz US drug products. The inspection resulted in three significant observations listed on an FDA Form 483. The primary issue, a repeat observation from a 2013 inspection, was the failure to report all serious and unexpected adverse drug experiences to the FDA within 15 calendar days. Out of 12,911 serious reports in 2016, 429 were submitted late, with an average delay of 258 days. Secondly, Novartis Pharma A.G. (operating as Sandoz) failed to notify the applicant holder of two serious unclassified adverse events for Nicardipine HCl Injection and did not submit these reports directly to the FDA within 15 days. Lastly, the firm demonstrated a failure to thoroughly review unexplained discrepancies. Investigations into late adverse event submissions lacked adequate root cause analysis, preventive actions, and follow-up. Furthermore, existing procedures did not clearly define roles or processes for tracking and investigating these late submissions. Novartis Pharma A.G. management acknowledged the observations and committed to providing a written response within 15 business days. The FDA also communicated potential legal sanctions, including seizure, injunction, and civil penalties, depending on further agency review.