Hospira gets Warning Letter from FDA after follow-up deemed inadequate

|By:, SA News Editor

Hospira (HSP -0.2%) receives a Warning Letter from the FDA after the agency reviewed the follow-up actions cited in its inspection of its Liscate, Italy manufacturing facility more than a year ago. The inspection occurred in May 2014 and the company submitted its response the next month.

FDA Director of Manufacturing Quality Thomas Cosgrove, J.D., cites a number of unresolved quality control issues and states that FDA representatives found similar problems in its December 2013 inspection of the company's Sriperumburdur, India plant.

The receipt of a Warning Letter requires prompt action. The company must respond to the letter within 15 days with its plan to address the deficiencies. If they remain unresolved, the FDA could withhold approval of new filings.

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