Amgen, Inc. – FDA Warning Letter, Jun 17, 2013

On January 27, 2014, the FDA issued a Warning Letter to Amgen, Inc. following an inspection from June 4-17, 2013, at their Thousand Oaks, California facility. The inspection found that Amgen's combination products, including Prolia, Enbrel lyophilized vial, and Enbrel prefilled syringe, had device constituent parts that were adulterated under section 501(h) of the Act, failing to conform to current good manufacturing practice requirements of 21 CFR Part 820 (Quality System regulation).

Specific violations included: 1. Failure to establish and maintain design validation procedures (21 CFR 820.30(g)). Amgen did not conduct design validation for Prolia's device constituent part prior to commercial release, as required by their own SOP. Amgen's response was inadequate as it did not describe future actions to ensure procedural adherence. 2. Failure to establish and maintain procedures for design change control (21 CFR 820.30(i)). Amgen failed to validate a design change to the Enbrel vial adapter in January 2010, which led to a significant increase in product complaints. Amgen's response was inadequate, lacking details on future procedural adherence and evidence that the problematic vial adapter was no longer in use. 3. Failure to establish and maintain requirements for