GlaxoSmithKline BiologicalsNovember 8, 2022

FDA 483 - GlaxoSmithKline Biologicals - November 08, 2022

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Record Details

An FDA inspection of GlaxoSmithKline Biologicals in Singapore revealed significant deficiencies in their quality system. Observations included inadequate documentation of investigations and CAPA effectiveness checks, improper identification of drug substance containers, and incomplete batch production and control records. These issues indicate a need for improved adherence to good manufacturing practices.

Company: GlaxoSmithKline Biologicals
Inspection Date: November 8, 2022
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Prabhu P. Raju (Program Expert for Advanced Manufacturing )

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ID · 606188b7-5f5e-4977-9606-59a6e8e0fa6d