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Hospira, Inc. (HSP) Gets FDA Notice Over Medical Device Problems


2/14/2013 7:18:43 AM

Hospira Inc, a hospital products maker that has grappled with regulatory issues at manufacturing plants for the past 18 months, said it had received a notice over the quality of its medical devices from the U.S. Food and Drug Administration. The company reported the notice during a conference call on Wednesday after announcing a profit for the fourth quarter vs a year-earlier loss as sales of generic injectable drugs, IV solutions, drug pumps and other products increased more than 8 percent. Hospira said the FDA completed an inspection of its medical device quality systems at its headquarters in Lake Forest, Illinois, last month and issued a list of 10 objectionable conditions. The list is known in the industry as a Form 483. Some of the quality systems assessed as part of the Lake Forest inspection included supplier quality systems and medical device reporting and complaint systems, a Hospira spokeswoman said. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted. Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections, the spokeswoman said. "While there may still be additional device field notifications going forward, we do not believe they will continue at the rate we have seen recently," she said in an email. Shares in Hospira fell $2.05 to $32.90 in afternoon trading on the New York Stock Exchange. Chief Executive F. Michael Ball said that FDA inspectors acknowledged some progress since the last inspection. "The observations re-enforced our own assessment there is still a lot of work to be done within our device operations," Ball said on the conference call.


   

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