FDA Blasts Medtronic Over Slow Drug Pump Recall

Law360, New York (June 26, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has blasted Medtronic Inc. for taking too long to recall defective SynchroMed II pumps in May 2008, claiming the medical device maker knew about problems at a manufacturing plant in Puerto Rico for nearly two years before issuing the recall.

The FDA also claims that Medtronic has failed to establish and maintain quality controls in manufacturing the products at the plant, which the agency discovered after conducting an inspection of the facility between November and December 2008, according to a...
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