FDA EIR - Dexcom, Inc. - March 22, 2018

An FDA Pre-Approval Inspection was conducted at Dexcom, Inc.'s Mesa, AZ facility from March 19-22, 2018. The primary purpose of this inspection, performed under the regulatory framework of a Pre-Market Approval (PMA P120005/S067), was to assess the Mesa site as a new, second manufacturing location for components of the Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems. Specifically, the inspection focused on the manufacturing processes for the sensor and transmitter parts of these critical medical devices. The inspection also included an abbreviated Quality System Inspection Technique (QSIT) evaluation, examining the company’s Management Review, Corrective and Preventive Action (CAPA), and Production and Process Controls subsystems. A significant finding of the inspection was that no FDA-483, indicating observations of significant violations or deficiencies, was issued. The report explicitly stated that 'Facilities and Controls were acceptable,' signifying that the site's operations met regulatory standards at the time of inspection. Consequently, the FDA determined that no further actions were required from Dexcom, Inc. The company was advised to continue its commitment to maintaining robust quality systems and vigilant oversight as its Mesa operations expand.