FDA Warns Baxter Over Infusion Pump Quality Controls

Law360, Washington (February 18, 2014, 2:07 PM EST) -- The U.S. Food and Drug Administration on Tuesday revealed it had sent Baxter Healthcare Corp. a warning letter in December urging it to correct deficiencies with its elastomeric medicine infusion pump procedures or face possible regulatory action, the second such letter targeted at Baxter to be unveiled in as many weeks.

According to the FDA’s letter, dated Dec. 19 but made public Tuesday, it had conducted an inspection of Baxter's Irvine, Calif.-based facility from December 2012 to June, discovering that the company’s procedures for its elastomeric...
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