FDA EIR - Hospira, Inc., A Pfizer Company - June 08, 2016

The FDA conducted a comprehensive Current Good Manufacturing Practice (cGMP), pre-approval, and basic medical device inspection of Hospira Inc. A Pfizer Company in McPherson, KS, from May 16 to June 8, 2016. The inspection, covering human and veterinary drug and combination drug/device manufacturing, identified significant and recurring deficiencies across multiple systems, resulting in a 14-item FDA-483. Major violations in the Quality Control Unit included a systemic failure to investigate root causes and implement corrective actions for widespread product problems, such as pervasive label degradation in ADD-Vantage products, with 96% of retained samples found defective. The company also demonstrated inadequate reserve sample inspection procedures and a consistent failure to submit timely NDA Field Alert Reports for critical issues like particulates and product discoloration, including for international distribution. For combination drug/device products, the firm failed to notify the FDA of major design changes to its iSecure delivery system and lacked proper design history file documentation. Production system deficiencies included inadequate microbial contamination prevention, the absence of crucial in-process defect limits for vial inspection despite a history of particulate complaints, and poor control over rejected materials. Packaging and Labeling issues involved accepting non-conforming labeling materials. Verbal observations also cited the manufacturing of unapproved Epinephrine Injection (though on a drug shortage list) and an inadequate particulate control improvement plan. The company was cautioned on its responsibilities to adhere to the Food, Drug, and Cosmetic Act, necessitating comprehensive and effective corrective and preventive actions to address these systemic issues.