FDA 483 - GlaxoSmithKline Biologicals - August 05, 2025

GlaxoSmithKline Biologicals in Singapore received a Form 483 for significant deviations in manufacturing sterile bulk drug substance. Observations included inadequate sterility testing procedures that deviated from their approved BLA, incomplete investigations into particle contamination and alarm system outages prior to product release, and a failure to timely submit a Biological Product Deviation Report for glass fragment contamination. These issues affected multiple batches of Hiberix drug product released to the U.S. market.