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FDA Issues Form 483 With 20 Observations On Hospira's Rocky Mount Facility

The U.S. Food and Drug Administration or FDA, on March 1, 2013, completed an inspection of Hospira, Inc.'s (HSP) facility in Rocky Mount, North Carolina, which was conducted by five inspectors over a three-week period. The company said it is making this disclosure because this facility has been subject to an FDA warning letter since April 2010. At the close of the inspection, the FDA issued a Form 483 with 20 observations, three of which were designated as repeat observations.

The pharmaceutical and medication delivery company would be seeking input from the FDA on the scope and timing of remediation efforts at the facility. For the past few years, the company along with FDA has been working to balance remediation efforts with the production of market critical drugs and would be dialoguing with the FDA as to whether this balance remains appropriate.

While the company is taking this matter seriously, any actions by it or the FDA with respect to this inspection could impact its ability to increase supply of products to the market, could impact its costs for remediation activities or have other adverse impacts on the company's operations.

In addition, Hospira is yet to evaluate whether there would be any financial impact from this matter, and if any would be included as part of its earlier announced intention to issue 2013 guidance as part of its first quarter 2013 earnings call.

by RTTNews Staff Writer

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