Hospira, Inc. – FDA 483, Mar 1, 2013

An FDA inspection conducted from February 12 to March 1, 2013, at Hospira, Inc. in Rocky Mount, NC, a sterile pharmaceutical manufacturer, identified significant deviations from Current Good Manufacturing Practice (cGMP) regulations. The main violations centered on inadequate production and process controls, particularly concerning aseptic media fill simulations and procedures to prevent microbiological contamination.Observation 1 highlighted the absence of comprehensive written procedures to assure drug product quality and purity. Specifically, media fills failed to accurately represent routine aseptic filling, lacking simulation of anaerobic conditions for relevant products and the full extent of manual interventions performed during production. Additionally, there were inconsistencies in documentation for manual interventions, insufficient training for visual inspection of media-filled vials, and unvetted microbial growth promotion test procedures.Observation 2 detailed deficiencies in preventing microbiological contamination. This included a lack of non-visible particulate monitoring to confirm ISO Class 5 air quality during capping for certain products, exposing them to unclassified environments. The facility also lacked proper validation and documentation for decontamination processes, including defined load configurations and critical parameter evaluations. Environmental control was further compromised by unassessed airflow patterns in critical zones, inconsistent personnel aseptic techniques, and undocumented life cycles for gowning attire. The environmental monitoring program lacked an evaluation of airflow patterns to determine appropriate sampling sites.Observation 3, noted as a repeat observation, indicated that the responsibilities and procedures for the quality control unit were not fully documented or followed, specifically regarding the prevention of product damage during overwrapping and unofficial practices to prevent line stoppages.Hospira, Inc. is required to implement robust corrective actions, including developing and rigorously following written procedures for all identified deficiencies, updating media fill protocols to accurately reflect actual manufacturing, validating critical processes like decontamination and environmental controls, and ensuring the quality control unit's procedures are comprehensively documented and adhered to.