FDA 483 - Hospira, Inc. - October 24, 2012

An FDA inspection conducted from October 9-24, 2012, at a human and veterinary drug manufacturing facility located in McPherson, KS, identified significant issues requiring corrective action. The inspection revealed two primary observations.Firstly, procedures designed to prevent microbiological contamination of sterile drug products were deemed inadequate. Specifically, personnel entryways, traffic flows, and gowning practices, including the use of dedicated plant shoes and shoe covers, were deficient. Employees in dedicated plant shoes were observed frequenting public areas like the cafeteria and warehouses, commingling with personnel wearing outside shoes, before returning to manufacturing areas. A sanitization step was deemed ineffective as employees immediately re-entered common areas. This practice was linked to an observed seasonal increase in environmental microorganisms in 2011 and 2012, indicating a failure to mitigate contamination risks.Secondly, investigations into unexplained discrepancies or failures were found to be insufficient in scope. For instance, two lots of Fentanyl Citrate for injection failed HPLC stability analysis due to impurities from rubber plungers. Despite identifying additional failing lots, the firm's investigation did not expand to comprehensively assess all currently distributed, unexpired lots. Similarly, two incidents of city water leaks from sprinkler heads in aseptic areas due to improper installation were not adequately investigated to evaluate the installation integrity of other sprinkler heads throughout the facility. These observations highlight a need for enhanced contamination control and more thorough investigative practices to ensure product quality and patient safety.