FDA EIR - GlaxoSmithKline LLC - August 09, 2012

An FDA inspection of GlaxoSmithKline, Inc.'s nonclinical research laboratory in Durham, NC, was conducted from August 6 to August 9, 2012. This four-day review evaluated the facility's adherence to Good Laboratory Practice (GLP) regulations, specifically Compliance Program 7348.808 for nonclinical laboratories. The inspection encompassed a review of three toxicology studies, laboratory operations, electronic data capturing systems, and various standard operating procedures. A key focus was assessing the company's response to verbal observations from a prior May 2010 inspection. These earlier concerns involved ensuring raw data was properly initialed and signed by the study director, accurate recording of time and temperature conditions, and timely archiving of study records. The August 2012 inspection concluded without any new observations or objectionable conditions, confirming that GlaxoSmithKline had successfully corrected the previously identified deficiencies, including an updated procedure for study record archiving. Consequently, no Form FDA 483, Inspectional Observations, was issued, and no specific corrective actions were mandated. Management was, however, reminded of their continuous responsibility to uphold all applicable GLP regulations.