FDA 483 - Medtronic Puerto Rico Operations Co. - October 25, 2019

Medtronic Puerto Rico Operations Co. in Juncos, PR, a medical device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, process validation, process controls, and the disposition of nonconforming products. These issues impacted devices such as Synchromed implantable sterile infusion pumps and NGP insulin infusion pumps.