FDA 483 - Hospira, Inc., A Pfizer Company - September 12, 2002

An FDA inspection of Abbott Laboratories in McPherson, KS, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm lacked an adequate environmental monitoring program, failed to monitor all personnel entering aseptic processing areas daily, and had not properly evaluated airflow patterns with smoke studies for component transfer and sealing activities.