FDA EIR - Teva Branded Pharmaceutical Products R&D - June 30, 2016

An FDA surveillance inspection of Teva Pharmaceuticals' corporate headquarters in Horsham, PA was conducted from June 8 to June 30, 2016. This unannounced inspection, operating under CPG 7353.001 for Postmarketing Adverse Drug Experience (PADE) reporting regulations, primarily focused on the company's systems for handling complaints and post-market adverse drug events.The inspection revealed several significant issues, leading to the issuance of a 6-item FDA Form 483. Main violations included the lack of documented written procedures for the receipt and reporting of postmarketing adverse drug experiences, and a failure to report all serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. Additionally, Teva was cited for not submitting quarterly periodic adverse drug experience reports and nonprescription drug adverse event reports within their respective deadlines. Deficiencies were also noted within the quality control unit, where written procedures were not reviewed or approved, and unit responsibilities were not consistently followed.Further discussions highlighted concerns about the absence of a mechanism to verify the delivery of adverse event follow-up letters, a significant delay in recalling the Zecuity product despite numerous burn complaints, and inadequate staffing contributing to late report submissions. Teva Pharmaceuticals submitted a written response to the FDA's observations on July 21, 2016, outlining its planned corrective actions.