FDA 483 - GlaxoSmithKline Biologicals - November 08, 2022

GlaxoSmithKline Biologicals in Singapore underwent an FDA inspection from October 31 to November 8, 2022, resulting in a Form FDA 483. The inspection identified significant observations related to quality systems and manufacturing controls for licensed biological products. Key issues included deficiencies in investigation records, specifically for unexplained discrepancies such as defects in aseptic process simulations, gaps in critical connectors, and recurring leak incidents. Investigations often lacked sufficient documentation for conclusions, justifications for not initiating Corrective and Preventive Actions (CAPAs), or proper effectiveness checks for implemented CAPAs. Furthermore, there was no documented verification of vendor actions for critical components. The FDA also observed that process containers used during drug substance production, specifically for Haemophilus influenza type b (Hib) polysaccharide, were not consistently identified with their contents, lot numbers, or processing phases. Additionally, batch production and control records for Hib batches were incomplete, documenting only "Yes" or "No" for in-process monitoring results instead of actual quantitative values. These observations indicate potential deviations from Good Manufacturing Practices (GMP) and require a comprehensive response from GlaxoSmithKline Biologicals, detailing corrective actions to address each deficiency and ensure future compliance.