Hospira, Inc., A Pfizer Company – FDA EIR, May 5, 2011

A four-day FDA inspection of Hospira Inc. in McPherson, KS, took place from May 2 to May 5, 2011. The inspection primarily focused on the firm’s Quality and Production Systems, covering drug, medical device, and biologic manufacturing operations. Although no formal FDA 483 inspectional observations were issued, verbal observations and discussions with management highlighted several areas requiring attention. Key issues included inaccuracies in the product complaint handling procedure, such as incorrect attachment references and a lack of explicit requirements for extending investigations to other potentially affected batches or products. Additionally, complaint investigations were not consistently completed within the stipulated 30-day timeframe. Discrepancies were also noted in the review of specifications for new or changed products, exemplified by a past labeling error for Lorazepam HCI regarding refrigeration. The regulatory framework emphasized compliance with quality and production standards. Management acknowledged these verbal observations, committing to implement corrections for the complaint procedures and investigation timelines. Furthermore, an updated Bill of Materials SOP and a revised labeling monograph were presented as corrective actions to address certain specification review and labeling issues, and were accepted by the investigators. The FDA encouraged the firm to define “recall” within its medical device procedures and to develop corrective actions for future external laboratory sampling processes.