483
GSK Vaccines GmbHFDA 483 - GSK Vaccines GmbH - March 06, 2024
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GSK Vaccines GmbH in Marburg, Germany, was cited for significant deficiencies during an FDA inspection. Observations included failures in preventing microbiological contamination of sterile drug products, inadequate investigation of discrepancies, and poor material segregation. Additionally, the firm was found to have incorrect expiration dates on drug product containers and accompanying documentation.
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ID · 17a156b1-1d2c-45e5-a69d-7e981fede4f2