FDA EIR - Hospira Inc. - October 24, 2012

An FDA current Good Manufacturing Practice (cGMP) inspection was conducted at Hospira Inc's McPherson, Kansas facility from October 9 to October 24, 2012. This comprehensive inspection evaluated all six manufacturing systems, as well as pre-approval and post-approval filings for various sterile injectable and combination device products. The inspection resulted in two formal observations documented on an FDA Form 483, along with significant verbal observations. Primary issues identified included inadequate plant gowning procedures, specifically regarding uniforms and shoes, which posed a risk of introducing contaminants into critical manufacturing areas. Furthermore, the firm failed to adequately investigate out-of-specification (OOS) results for total impurities in Fentanyl Citrate Injection during stability testing and did not expand investigations to determine the full scope of affected product lots. A similar deficiency was noted in the investigation of leaking fire sprinkler heads in aseptic processing areas, where the firm failed to assess all potentially impacted sprinkler heads across manufacturing zones. A repeat verbal observation underscored concerns about automated vision inspection systems for ampul and fill lines operating at speeds too fast for effective quality control. These findings indicate areas of non-compliance with FDA's cGMP regulations. While specific detailed actions mandated by the FDA are not fully outlined in this report excerpt, Hospira Inc is expected to address these observations by implementing robust corrective and preventive actions (CAPA), including expanding investigations where necessary, and enhancing their quality systems to ensure ongoing adherence to regulatory standards for drug product quality and patient safety.