FDA EIR - Hospira, Inc., A Pfizer Company - August 27, 2009

A directed Pre-Approval and Biologic product manufacturing inspection of Hospira Inc. in McPherson, KS, was conducted by the FDA from August 18-27, 2009. The inspection, guided by C.P. 7356.002M and C.P. 7346.832, focused on Quality, Materials, Production, Laboratory, and Facilities systems for an NDA product and various biologic products, ensuring adherence to applicable CFRs (601, 610, 210, 211). Notably, no FDA 483 Inspectional Observations were issued at the inspection's conclusion. However, the inspection did identify an ongoing internal investigation (Exception Report 2915) at the firm. This investigation concerned the Environmental Monitoring System (EMS) alarm, which was inadvertently deactivated for several days (July 23-August 3, 2009) following routine cleaning. As a result, all product lots manufactured during this period were isolated and placed on hold pending the investigation’s resolution. Hospira Inc. was reminded of its fundamental responsibility to comply with the Food, Drug, and Cosmetic Act, highlighting the potential for FDA enforcement actions if adherence is not maintained.