Amgen Inc. – FDA EIR, Sep 3, 2010

The FDA inspected Amgen Inc.'s Boulder, CO facility from August 23 to September 3, 2010. This inspection, conducted under Compliance Program 7356.002M for licensed biological therapeutic drug products like Kineret and Denosumab, identified several issues. An FDA-483, Inspectional Observations, was issued to Amgen's Vice President, Colorado Operations. The main violations included incomplete Level 4 gowning procedures, specifically regarding the correct handling of sterile sleeve cuffs. Additionally, there was a failure to follow Level 3 gowning procedures, with personnel not completely covering their hair. Lastly, the firm did not adhere to its written procedures for alarm responses, as numerous excursion reports were voided without adequate justification, proper approval from Quality Assurance, or complete documentation of the reasons. Amgen's management committed to implementing necessary corrections and providing a written response to the FDA within 15 business days. Initial corrective actions included revising relevant Standard Operating Procedures for gowning and alarm response.