FDA EIR - Amgen Manufacturing Ltd - April 11, 2019

An FDA inspection of Amgen Manufacturing Limited in Juncos, Puerto Rico, was conducted from April 1 to April 11, 2019. The inspection focused on the company's manufacturing of licensed biologics, sterile drug products, combination products, and oral solid dosage forms, specifically reviewing quality, production, and materials systems. A comprehensive evaluation of the complaint system was performed due to numerous consumer complaints regarding combination products like Enbrel, Repatha, and Aimovig, often citing autoinjector and syringe malfunctions. The regulatory framework for the inspection included the Food, Drug, and Cosmetic Act and 21 CFR Part 820 for medical devices, covering management, design, CAPA, and purchasing controls. Upon conclusion, an FDA Form 483 was issued to Mr. Rayne M. Waller, Vice President of Regional Manufacturing, outlining significant deficiencies. These included a lack of adequate quality control unit oversight for product impact from complaints, insufficient complaint procedures failing to mandate manufacturing investigations for adverse events, and untimely submission of a Biologic Product Deviation Report. Further issues noted were inadequate design transfer verification for Enbrel Mini, deficiencies in Corrective and Preventive Action (CAPA) procedures regarding expansion to other products and effectiveness checks, and inadequate supplier qualification processes for confirmed quality issues. Amgen committed to taking corrective action and providing a written response to the FDA within 15 business days.