FDA 483 - GSK Vaccines GmbH - February 27, 2026

GSK Vaccines GmbH, a licensed biological drug manufacturer in Marburg, Germany, was cited for significant deficiencies in its Aluminum Hydroxide adjuvant production. The inspection revealed unvalidated cleaning procedures, inadequate cleaning verification monitoring, and a failure to properly investigate recurring cleaning failures for dedicated equipment. Furthermore, the firm did not thoroughly review unexplained discrepancies or conduct formal investigations for repeated test failures related to the adjuvant filling equipment, impacting U.S. licensed products.