FDA 483 - GlaxoSmithKline, LLC. - January 25, 2018
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An FDA inspection of SmithKline Beecham (d.b.a GlaxoSmithKline), a Fermented Biotech API Manufacturer, identified two significant observations. The firm's Standard Operational Procedures (SOPs) were found to be incomplete, specifically lacking instructions for documenting and reviewing cell bank passages for Mepolizumab Drug Substance production. Additionally, the Hold Time Study for Buffers and Shelf-life Study for Medium were incomplete, with missing buffer names and discrepancies between study conclusions and batch record storage instructions for Mepolizumab shake flask medium.
ID · d1a3cd11-06e2-4ab5-81cb-47552bfe467a