GlaxoSmithKline LLC – FDA EIR, Jul 15, 2016

An FDA inspection of GlaxoSmithKline (GSK) in Durham, NC, was conducted from July 12-15, 2016. The inspection focused on ensuring compliance with postmarketing adverse drug experience (PADE) reporting laws and regulations under the Food and Drug Cosmetic (FD&C) Act, and adherence to the Risk Evaluation and Mitigation Strategy (REMS) program for the drug Tanzeum. While a formal Form FDA-483 (Inspectional Observations) was not issued, the inspection highlighted several areas for improvement. Main issues discussed with management included the need to formally integrate all training guidances, particularly for after-hours reporting and electronic submissions, into employee training curricula and evaluate them for official approval. Additionally, inconsistencies were noted in the documentation and verbiage of corrective and preventive actions (CAPAs) for 15-day late adverse drug experience reports, underscoring the necessity for standardization to facilitate effective trending and prevent recurrence. A previously resolved issue involved an incorrect system configuration for an over-the-counter product (Gaviscon), which led to paper submissions to the wrong FDA center. GSK management acknowledged and agreed to address the discussed observations.