FDA Review Adds To Hospira's Regulatory Woes

Law360, New York (February 13, 2013, 5:46 PM EST) -- Hospira Inc. disclosed Wednesday that the U.S. Food and Drug Administration had uncovered a number of potential quality-control violations at one of company's sites, adding to the device maker's recent regulatory headaches.

The revelations, which emerged during an earnings call, concern operations in Hospira's hometown of Lake Forest, Ill., where FDA inspectors turned up 10 "observations" during the fourth quarter of 2012 that signal preliminary findings of operational shortcomings, according to the company. According to Hospira, the issues relate to medical device reporting and complaint systems used to monitor customer feedback.

F. Michael Ball, Hospira's CEO, said the company had received...

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