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Manufacturing Problems for Intravenous Emulsions

Many of the drug products manufactured by Hospira, including intravenous nutritional emulsions and propofol have been on the market for years. Hospira received a warning letter on April 12th citing two of its intravenous drug product manufacturing plants in North Carolina. The sites were inspected by the FDA in April 2009, and the violations cited were never addressed to the satisfaction of the FDA. Items listed in the letter were particulates due to equipment failure, inadequate manufacturing validation and deficiencies in Hospira’s quality control procedures.

In November 2009, it appears that many of these same issues had not yet been corrected and Hospira issued a nationwide voluntary recall of various intravenous emulsion products due to particulate matter, identified as stainless steel from equipment used in the manufacture of the emulsion products.

The moral of this story, do not ignore the findings of an FDA inspection. Define a plan, provide an outline to the FDA and execute the plan. Hospira might have avoided a costly recall and a subsequent warning letter, if a valid corrective action plan was in place and the GMP violations were being addressed adequately. The result of these manufacturing issues pending can be directly linked to a nationwide shortage of propofol, and a major cost to Hospira.