Dexcom, Inc. – FDA EIR, Apr 21, 2015

An FDA compliance follow-up inspection of Dexcom, Inc., a San Diego-based manufacturer of Class III continuous blood glucose monitoring systems (Dexcom G4 Platinum), was conducted from April 16-21, 2015. This inspection aimed to verify corrections following a previous October-November 2013 inspection, which resulted in a Warning Letter (16-14). The prior violations included significant failures in Medical Device Reporting (MDR), specifically not reporting deaths, serious injuries, or device malfunctions in a timely manner, and failing to establish adequate written MDR and complaint handling procedures. The current inspection, conducted under Compliance Program Guide Manual 7382.845 for medical device manufacturers, covered Management Controls, Design Controls, Corrective and Preventative Actions (CAPA), and Production & Process Controls. Dexcom, Inc. had implemented CAPA-2013-033 to address the previous MDR reporting issues, identifying root causes such as inadequate procedures, administrative tools, and training. Corrective actions involved revising relevant procedures for customer complaints, US Medical Device Reporting, and quality record retention, alongside comprehensive employee training. Crucially, the FDA investigator issued no FDA 483-Inspectional Observations during this inspection, indicating that no new significant deviations were found, and the firm's corrective actions for the prior violations, particularly concerning MDR and complaint handling, were deemed adequate.