FDA EIR - Hospira, Inc., A Pfizer Company - May 25, 2012

An FDA inspection of Hospira Inc. in McPherson, KS, was conducted from May 22 to May 25, 2012, primarily focusing on recent recalls and field alerts concerning overfilled Carpuject drug products. The investigation identified the root cause of these overfills as operator failure to follow proper sequencing during the filling process on a specific manufacturing line. This issue was compounded by a stressed workforce due to increased production demands. While no FDA Form 483 was issued during this inspection, a verbal observation was conveyed to management. This observation highlighted a delay in submitting required FDA Field Alerts within the mandated three-day timeframe following awareness of product non-conformance. Hospira had initiated several corrective actions to address the overfills. These included reprogramming equipment to enforce correct operational sequences, enhancing quality oversight for line restarts after downtime, revising batch records to specifically document overfills as critical quality non-conformances, and planning the implementation of an automated vision system across all Carpuject lines to detect excess fill volumes. Management acknowledged their responsibility to comply with the Food Drug & Cosmetic Act.