FDA 483 - GSK Vaccines GmbH - November 12, 2024

During an inspection conducted from November 4-12, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to GSK Vaccines GmbH in Marburg, Germany, identifying significant deficiencies in their vaccine bulk product manufacturing operations for Shingrix and Measles. The inspection revealed that the company's facilities and equipment were poorly maintained, with observations including liquid leaks, various residues on critical manufacturing components, and deteriorated structures in classified production areas, indicating a failure to ensure product quality.

Furthermore, critical utilities essential for Shingrix production lacked adequate qualification and routine monitoring, and their use continued without completed validations. The FDA also noted a substantial lack of quality oversight and data integrity for electronic records related to manufacturing equipment, environmental monitoring, and process control systems. This included missing documentation, uninvestigated failed equipment self-tests, and aborted environmental monitoring without proper review or investigation. Deviation management was found inadequate, with critical alarms going unreviewed, and manufacturing proceeding despite known high bioburden levels in a contamination source. Overall, there was insufficient quality oversight to assure the identity, strength, quality, and purity of the vaccine drug substances. The company is required to address these observations in accordance with Good Manufacturing Practices.