FDA 483 - GSK Vaccines GmbH

An FDA inspection of GSK Vaccines GmbH in Marburg, Germany, identified significant deficiencies in the manufacture of Shingrix and Measles bulk drug substances. Observations included poorly maintained facilities and equipment, inadequate qualification and monitoring of critical utilities, and a lack of quality oversight for electronic data and deviation management. These issues raise concerns about the identity, strength, quality, and purity of the drug substances produced.