FDA EIR - Medtronic MiniMed, Inc. - August 14, 2017

An FDA post-market inspection of Medtronic Inc.'s Northridge, CA facility was conducted from July 24 to August 14, 2017. The inspection focused on the iPro2 CGM System with Enlite 1 Sensor, a Class III medical device, under the regulatory framework of PMA Postmarket Inspections and Inspection of Medical Device Manufacturers programs, utilizing the Quality System Inspection Technique (QSIT) methodology. Although no formal FDA-483 observations were issued, the inspection identified four significant issues that were discussed with Medtronic management. These included the failure to open a supplier corrective and preventive action (SCAPA) regarding a visual inspection inadequacy by a sensor substrate supplier (Metrigraphics), the lack of a complete device history index (DHF) for the iPro2 CGM System, an incomplete Medical Device Report (MDR) submission missing product codes, and an omission in the iPro2 CGM System User Guide regarding the single-patient use of the Enlite Serter. Medtronic management, including Vice President of Quality Assurance, Mr. Dabbs, acknowledged these deficiencies. Corrective actions for the first three items were initiated during the inspection, and the firm's leadership committed to implementing corrective actions for all discussed issues to ensure compliance and quality system effectiveness.