483
GlaxoSmithKline dba Human Genome Sciences IncFDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - March 15, 2019
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Record Details
An FDA inspection of GSK's drug substance manufacturing site in Rockville, MD, revealed significant issues with quality oversight and adherence to written procedures. The firm failed to correct errors in executed production records for liquid drug substance manufacturing. Additionally, written procedures were not followed during manufacturing operations, including improper sample collection and inadequate equipment cleaning.
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ID · d826d0ff-2abb-4e17-978e-118bec3fad2e