FDA EIR - Hospira, Inc., A Pfizer Company - April 23, 2014

The FDA conducted a comprehensive inspection of Hospira Inc.'s manufacturing facility in McPherson, KS, from April 14-23, 2014. This inspection covered drug and device manufacturing under cGMP regulations, focusing on Packaging and Labeling, Facilities and Equipment, Materials, and Quality Systems, as well as pre-approval applications for new drugs. The inspection resulted in a 2-item FDA 483, citing deficiencies in process validation activities and inadequate capturing of information in complaint investigations. Additionally, three verbal observations were given, addressing the need to improve visual inspection training for particulates, enhance control practices for packaging and labeling to prevent using out-of-date materials, and rectify annual product review deficiencies. Notably, this facility has a history of similar issues. Previous inspections in 2013 and 2012 identified failures in filing field alerts for glass particulates, inadequate investigations, and deficiencies in 100% visual inspection processes and validation. Recalls for missing labels and embedded particulate matter in vials (Lidocaine, Marcaine, Demerol) were also covered, highlighting persistent challenges in quality control and complaint management. A significant concern revolved around embedded particulate in glass vials, leading to recalls. Hospira is actively collaborating with its glass vendor, implementing corrective and preventive actions, including supplier audits and enhanced component qualification processes for glass and stoppers. The FDA recommended withholding approval on applications pending a complete and acceptable response from Hospira. The company must continue to strengthen its quality systems to ensure consistent compliance.