FDA 483 - Pharmacia & Upjohn Company LLC - May 11, 2021

An FDA inspection of Pharmacia & Upjohn Company, LLC in Kalamazoo, Michigan, a licensed biological drug manufacturer, identified significant deficiencies in quality systems related to COVID-19 vaccine production and general manufacturing controls. Observations included inadequate operator awareness and SOPs leading to unlabeled vaccine vials, insufficient review of personnel monitoring excursions, and failures in investigation follow-up and CAPA effectiveness checks. Additionally, the firm did not properly review and approve changes to written procedures, including a validated cleaning process, and had an inadequate SOP change management template.