FDA 483 - Hospira, Inc., A Pfizer Company - August 30, 2007

This FDA Form 483 was issued to Hospira, Inc. in McPherson, KS, following an inspection from August 20-30, 2007. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental monitoring, poor aseptic technique by operators, failure to follow cleaning procedures, and insufficient validation of sterilization processes. These issues indicate a high risk of microbiological contamination for sterile drug products.