FDA 483 - Hospira, Inc., A Pfizer Company - March 02, 2026

Hospira, Inc. in McPherson, KS, a drug product manufacturer, was inspected by the FDA from March 2-10, 2026. The inspection revealed significant deficiencies across multiple areas, including inadequate process controls for sterile drug product manufacturing, poorly designed and maintained equipment and facilities, deficient laboratory and gowning procedures, and a lack of adequate quality control unit oversight and documentation controls. These issues indicate a systemic failure to ensure drug product quality and sterility.