FDA 483 - GSK Vaccines GmbH

An FDA inspection of GSK Vaccines GmbH in Marburg, Germany, revealed six observations concerning the manufacture of Shingrix and Measles bulk drug substances. Key issues include deficient maintenance of facilities and equipment, inadequate qualification and monitoring of critical utilities, and significant lapses in quality oversight for electronic data integrity and deviation management. These findings indicate a lack of control over critical manufacturing processes and potential risks to product quality.