FDA Warns Hospira, Inc. -- Again

Published: May 16, 2013

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Hospira Inc. has received another warning letter from the U.S. Food and Drug Administration, adding to a string of bad news stretching back nearly two years. The May 9 letter describes a dozen deficiencies in design and quality assurance processes for medical devices that FDA officials found during an inspection at the company's headquarters in Lake Forest. The warning letter is an indication that the FDA wasn't satisfied by Hospira's response to a list of deficiencies that was issued after the Jan. 27-Feb. 3 inspection. The warning letter also finds flaws with Hospira's decision to phase out some lines of IV pumps, which was disclosed early this month.

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