FDA 483 - Amgen Manufacturing Ltd - May 10, 2017

Amgen Manufacturing Limited in Juncos, PR, was cited for deficiencies in its quality system during an inspection of its human drug manufacturing facility. The firm failed to adequately investigate product complaints for trends and causes, particularly for products like Enbrel and Repatha. Additionally, the annual product review for Enbrel did not include a required evaluation of complaints, despite distributed batches being within shelf life.