FDA 483 - Amgen Manufacturing Ltd - May 08, 2019

Amgen Manufacturing Limited (AML) in Juncos, PR, was inspected and cited for significant issues in its Enbrel drug substance manufacturing. Observations included inadequate contamination controls, insufficient performance qualification, ineffective corrective actions for leaks, and non-conformance with the Biologics License Application. These deficiencies led to bacterial contamination and discontinuation of multiple commercial batches.