FDA 483 - Medtronic Puerto Rico Operations Co. - May 15, 2018

An FDA inspection of Medtronic Puerto Rico Operations Co. in Juncos, PR, revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish and implement procedures for corrective and preventive actions, process validation, acceptance activities, sampling plans, equipment calibration, and rework. These issues are particularly concerning as they relate to confirmed product failures, specifically electrical arcing in implantable cardiac defibrillators, which can impact device safety and performance.