Amgen responds to FDA warning letter over drug/device combos

Amgen ($AMGN) has been issued an FDA warning letter for problems the agency says it found at its plant in Thousands Oaks, CA, which makes prefilled syringes and related devices used for its osteoporosis drug Prolia, and for Enbrel, the autoimmune disease treatment it shares with Pfizer ($PFE). The letter, issued in January, was posted last week to the FDA's website, FierceMedicalDevices reported. In a statement, the company said, "Amgen takes these issues very seriously and we have implemented changes to our procedures. We are committed to working with the FDA to take appropriate measures and provide the necessary information to address the concerns raised in the letter." Among other issues, inspectors said Amgen lacked procedures to make sure the devices were properly vetted or designed to meet users' needs. Story | Letter