FDA 483 - Corixa Corporation d.b.a. GlaxoSmithKline - March 04, 2022

Corixa Corporation d.b.a. GlaxoSmithKline in Marietta, PA, a drug manufacturer, received a Form 483 with two observations. The inspection found deficiencies in packaging facility line clearance procedures, resulting in materials from previous batches remaining on the line. Additionally, investigations into batch failures lacked complete conclusions and follow-up, specifically regarding the assessment of impacted products.