FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - April 26, 2013

An FDA inspection of Human Genome Science, Inc.'s drug substance manufacturing facility in Rockville, Maryland, revealed significant deficiencies across multiple systems. Observations included inconsistent manufacturing processes, inadequate endotoxin controls, unvalidated media and buffer hold times, and an ineffective preventive maintenance program. The firm also demonstrated inadequate investigations, insufficient corrective and preventive actions, and a failure to follow or adequately document written procedures.