FDA 483 - GSK Vaccines GmbH - March 06, 2024

During an inspection conducted from February 26 to March 6, 2024, the U.S. Food and Drug Administration issued a Form 483 to GSK Vaccines GmbH, a licensed biological drug manufacturer in Marburg, Germany. The inspection revealed several significant observations related to manufacturing practices and quality control, indicating potential non-compliance with the Federal Food, Drug and Cosmetic Act. Key issues included deficiencies in procedures designed to prevent microbiological contamination of sterile drug products, specifically during MenA and RabAvert vaccine production. Operators failed to follow protocols for rejecting vials after interventions and lacked proper documentation, while an aseptic area was compromised without subsequent sanitization. Furthermore, the firm’s investigation into an unexplained discrepancy involving the critical raw material Aluminum Hydroxide, used in vaccines like Infanrix and Boostrix, was deemed inadequate, failing to fully assess the impact on equipment. Storage practices also raised concerns, with expired or obsolete materials not being adequately segregated or transferred to designated quarantine locations, leading to potential mix-ups. Finally, the FDA observed that finished drug product containers and accompanying distribution documents had incorrect expiration dates, which were not supported by stability studies. GSK Vaccines GmbH is required to respond to these observations with comprehensive corrective and preventive actions to ensure the safety, quality, and efficacy of its products.