FDA EIR - GlaxoSmithKline LLC - August 23, 2013

An FDA inspection of GlaxoSmithKline LLC (King Of Prussia, PA) was conducted from August 1 to August 23, 2013. This inspection, focusing on the Biologics License Application (BLA) for Albiglutide (GSK716155), a new molecular entity for Type 2 diabetes, operated under Good Clinical Practice (GCP) guidelines for sponsors and contract research organizations. At the conclusion, a four-point Form FDA 483 (Inspectional Observations) was issued. The primary violations included the company's failure to provide adequate data and analyses in the final clinical study report, specifically concerning retrospective measurements of outdated amylase, lipase, and other parameters, as well as a report on pen failures. Furthermore, GSK failed to ensure the investigation adhered to the general investigational plan and protocols, and to properly monitor the study for protocol compliance. A significant observation was the failure to terminate an investigator who did not comply with the signed agreement and investigational plan, even after an IRB termination of approval for non-compliance. Additional issues discussed included temperature excursions, the inclusion of data from duplicate subjects in integrated analyses, and deficiencies in sponsor/Contract Research Organization oversight, particularly regarding pharmacokinetic sample collection. GSK committed to submitting a written response to the Philadelphia District Office within 15 business days.