Actavis Elizabeth LLC, A Company of Teva – FDA EIR, Apr 26, 2011

An FDA Postmarketing Adverse Drug Experience (PADE) inspection of Actavis Elizabeth LLC, located in Elizabeth, NJ, was conducted from April 7 to April 26, 2011. This inspection, guided by regulatory frameworks for human drug postmarketing surveillance and drug quality reporting, identified significant issues in the company's adverse drug event (ADE) reporting system. Key violations included a lack of timely review of ADE information from the legal department and scientific literature, and failures to investigate discrepancies in monthly case reconciliations. The company also submitted serious and unexpected 15-Day Alert reports late to the FDA for various products, including Metoclopramide, Digoxin, and Fentanyl. Furthermore, there was an absence of written procedures for altering case assessments, training sales force personnel on ADEs, and evaluating ADE case processing by third-party contractors. The company also lacked the ability to generate reports on case status changes and had discontinued reviewing ADEs from the poison control database. These issues echoed deficiencies from a previous 2008 inspection regarding late and unreported ADEs. An FDA Form 483, Inspectional Observations, was issued. Actavis management, including Director of U.S. Medical Affairs Sarita Thapar and VP of U.S. Quality Nasrat Hakim, committed to addressing all observations and submitting a written response outlining corrective actions within two weeks. Planned actions include implementing written procedures, auditing contractor sites for consistency, reinitiating poison control database review, and developing a comprehensive signal detection system.