Inability to Trend for Defects Results in 483 for Medtronic

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. The company only investigates when all the devices that are part of the same family together exceed the pre-calculated threshold for a specific defect or hazard, according to a March 10 Form 483. Medtronic is working with the FDA to address the concerns and has an action plan in place, company spokesman Christopher Garland said.
The GMP Letter