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Home » Inability to Trend for Defects Results in 483 for Medtronic
Inability to Trend for Defects Results in 483 for Medtronic
October 7, 2010
Medtronic Puerto Rico Operations’ process of evaluating adverse product tendencies is unable to establish adverse tendencies for individual products, so the company does not always conduct the appropriate investigations, according to a March 10 Form 483.