FDA 483 - Hospira, Inc., A Pfizer Company - June 30, 2023

An FDA inspection of Hospira Inc., A Pfizer Company in Mcpherson, KS, identified a significant issue related to the prevention of microbiological contamination in sterile drug products. The inspection observed apparent leaks in the (b) (4) system on two separate occasions, indicating a failure to establish and follow appropriate written procedures. These findings suggest potential risks to the sterility of drug products manufactured at the facility.