FDA 483 - Hospira, Inc., A Pfizer Company - March 10, 2026

This summary details the findings from an FDA inspection of Hospira, Inc., located in McPherson, Kansas, conducted between March 2 and March 10, 2026. The inspection identified several critical deficiencies in the firm’s drug manufacturing processes and quality oversight. Primary concerns include a failure to maintain sterile conditions; inspectors observed personnel with exposed skin and improper gowning assembling equipment near open product lines. Additionally, facility maintenance was inadequate, noted by visible rust, leaks, and deteriorated sealants in production areas. Procedural gaps were also identified, specifically regarding inconsistent microbiological testing methods and a lack of formalized training for laboratory staff. The Quality Control unit demonstrated insufficient oversight, failing to align preventative maintenance with risk assessments and failing to resolve recurring equipment deviations. Finally, the company lacked proper documentation controls, with numerous laboratory notebooks remaining unaccounted for or unarchived for decades. Under the regulatory framework of the Food, Drug, and Cosmetic Act, these observations require Hospira to provide a formal response to the FDA detailing their planned corrective actions and improvements to ensure product safety and quality.