483
GlaxoSmithKline BiologicalsFDA 483 - GlaxoSmithKline Biologicals - November 08, 2022
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.
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ID · 606188b7-5f5e-4977-9606-59a6e8e0fa6d