FDA 483 - Burgwedel Biotech GmbH - August 29, 2023

Burgwedel Biotech GmbH, a biologics vaccine manufacturer, was cited for failing to justify deviations from written sampling plans and test procedures. The inspection revealed a lack of thorough review for unexplained discrepancies from their contract testing lab concerning stability studies for the ERVEBO vaccine. This included multiple instances of missed stability time points, use of expired media, and sample mismanagement, indicating inadequate oversight of critical outsourced testing.