FDA 483 - Hospira, Inc., A Pfizer Company - January 17, 2020

This FDA Form 483 report for Hospira Inc. in Mcpherson, KS, identifies significant deficiencies in the firm's sterile drug manufacturing processes. Repeated observations highlight persistent issues with quality control, inadequate process validation, and insufficient investigation procedures. The findings indicate a systemic lack of assurance regarding sterile drug product quality and patient safety.