FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - December 11, 2023

An FDA inspection of Humon Genomics Sciences, Inc. in Rockville, MD, revealed significant deficiencies in their drug substance manufacturing processes. Observations included inadequate microbial control, ineffective root cause analysis and CAPA implementation, and failures in data integrity and training procedures. Additionally, the firm lacked appropriate identity testing for raw materials and adequate control over manufacturing components.