Hospira, Inc., A Pfizer Company – FDA EIR, Jan 17, 2020

An FDA inspection of Hospira Inc., a Pfizer Company, located in McPherson, KS, took place from December 9, 2019, to January 17, 2020. Conducted as a follow-up "for cause" inspection, it assessed the firm's adherence to Good Manufacturing Practices for sterile drug, animal drug, and biological product manufacturing. This inspection built upon a history of non-compliance, including an 8-item FDA Form 483 issued in 2018, which led to an "Official Action Indicated" classification and a 2017 Warning Letter. The current inspection identified ten significant violations. Key issues included the Quality Control Unit's failure to adequately investigate drug product contamination, such as incidents involving a Daptomycin recall and Carpuject syringe issues. The firm also failed to properly monitor and validate systems used for component washing and sterilization, and exhibited inadequate contamination control due to exhaust system deficiencies and improper pressure differentials. Other observations highlighted a failure to follow written production procedures, thoroughly review unexplained discrepancies, and adequately validate aseptic and sterilization processes. Investigation records and master production records were found incomplete, and quality control sampling and testing were insufficient to ensure product conformity. At the inspection's conclusion, management was reminded of their responsibilities under the Federal Food, Drug, and Cosmetic Act. They are required to submit a comprehensive written response to the FDA Form 483 observations within 15 business days, detailing the corrective and preventive actions planned to address these systemic deficiencies and achieve regulatory compliance.