FDA EIR - Hospira, Inc., A Pfizer Company - October 27, 2017

A follow-up FDA inspection of Hospira Inc. A Pfizer Company in McPherson, KS, was conducted from October 16-27, 2017. This comprehensive cGMP inspection, covering human and veterinary drug manufacturing, including sterile drug processes, licensed biologics, and medical devices, aimed to assess compliance following a February 2017 Warning Letter related to a prior 2016 inspection.

The inspection revealed significant, often recurring, deficiencies across multiple systems. Key violations included widespread failures within the Quality Control Unit, such as inadequate root cause investigations for product problems (e.g., label adhesion, particulates) and insufficient expansion of investigations beyond individual lots to entire product lines. The firm consistently failed to submit NDA Field Alert Reports within the required three working days for out-of-specification results or serious product defects.

Deficiencies in manufacturing processes included inadequate visual inspection limits for particulates, improper control of rejected materials, and non-adherence to aseptic cleaning procedures. For combination drug/device products, Hospira failed to notify the FDA of major design changes for its iSecure device and did not maintain complete design history files. Furthermore, issues were identified with employee training, equipment qualification for automated visual inspection, and environmental monitoring during aseptic processing. An FDA Form 483, detailing these 10 observations, was issued, emphasizing that many were repeats of prior inspection findings. Management was reminded of their responsibilities under the Food, Drug, and Cosmetic Act.