FDA 483 - Hospira, Inc., A Pfizer Company - January 17, 2025

Hospira, Inc., a Pfizer Company, a sterile human drug manufacturer in Mcpherson, KS, was cited for significant deficiencies in its quality system. The inspection revealed failures in aseptic process controls, including inadequate media fill simulations and water sampling, as well as a lack of established limits for individual defects during visual inspection. Furthermore, the firm failed to thoroughly investigate an out-of-specification microbial contamination event in a compounding room, indicating a serious lapse in quality control and risk assessment.