FDA EIR - GlaxoSmithKline LLC - April 10, 2015

An FDA inspection of GlaxoSmithKline (GSK) in Durham, NC, occurred from April 6-10, 2015. Conducted under the Bioresearch Monitoring-Sponsor regulatory framework, the inspection focused on two investigational drug protocols (MEA112997 and MEA115588) concerning severe asthma. The primary areas reviewed included site monitoring, training, adverse event reporting, and subject eligibility criteria for these global clinical studies. The inspection concluded with no significant objectionable conditions or practices observed, and no FDA Form 483 (Inspectional Observations) was issued to management. While no formal violations were cited, discussions with management addressed specific concerns. These included internal quality issues related to investigational product unblinding, for which GSK had already implemented corrective actions. Additionally, the FDA clarified reporting requirements for Serious Adverse Events involving subject deaths, emphasizing that unexpected deaths should be reported within seven days, irrespective of suspected causality, a point which management acknowledged for future adherence. The inspection report and exhibits were forwarded to CDER for final review and classification.