FDA 483 - Amgen Manufacturing Ltd - April 11, 2019

Amgen Manufacturing Limited in Juncos, PR, a biologic biotech manufacturer, received a Form FDA-483 citing six observations related to significant quality system deficiencies. These issues include inadequate quality control unit procedures, deficient complaint handling, failure to submit biological product deviation reports, insufficient design verification for combination products, and poorly established corrective and preventive action processes, as well as inadequate supplier controls. The observations highlight systemic failures that led to defective auto-injectors and prefilled syringes reaching end-users.