FDA EIR - Hospira, Inc. - January 19, 2010

An FDA inspection of Hospira, Inc.'s Rocky Mount, NC facility, conducted from January 12-19, 2010, identified significant regulatory violations primarily concerning process validation for both drug and medical device products. The inspection, conducted under Good Manufacturing Practices (21 CFR Part 211) and Quality System Regulation (21 CFR Part 820) frameworks, focused on compliance for intravascular catheters containing heparin and related solutions.

Key issues cited on the FDA Form 483 included the failure to adequately validate solution tank mixing processes for various drug products and heparin lock flush solutions. The company also lacked a statistically and scientifically sound rationale for applying its mixing validation matrix to numerous products and failed to identify critical process control parameters for heparin lock flush solutions. Additionally, critical batch records from a 2003 heparin mixing validation study were destroyed, and visible particulates observed during a validation run were not investigated. Concerns were also raised about the firm still reporting adverse events for reclassified heparin products (now considered medical devices) to the Center for Drug Evaluation and Research (CDER) instead of the Center for Devices and Radiological Health (CDRH).

In response, Hospira management initiated a high-level Exception Report to assess validation program lapses and their impact, committing to a comprehensive review as a corrective measure. They also promised a written response to the FDA 483 within 15 business days. A follow-up drug inspection was recommended to thoroughly evaluate Hospira's validation program.