FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc

Human Genome Sciences, Inc. in Rockville, MD, a drug substance intermediate manufacturer, received a Form 483 with three observations. The inspection revealed issues with the manufacturing process, including undocumented repeated steps and non-conforming batch numbering. Additionally, the firm failed to follow written procedures for deviation reporting and investigation, and employees were not adequately trained prior to performing manufacturing operations.