Corixa Corporation d.b.a. GlaxoSmithKlineMarch 4, 2022

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

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Record Details

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.

Company: Corixa Corporation d.b.a. GlaxoSmithKline
Inspection Date: March 4, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Viviana Matta (FDA Biologics Investigator)
Pankaj Amin, CSO
Burnell M. Henry (Investigator)

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ID · 66b7f6dc-5234-4cb2-9241-fd571a6609fb