FDA EIR - Dexcom, Inc. - February 16, 2018

An FDA inspection of Dexcom Inc. in San Diego, CA, was conducted from February 12 to 16, 2018. This high-priority inspection focused on validating sponsor data for a clinical trial related to a significant risk medical device, conducted under the Bioresearch Monitoring program. The review assessed various aspects, including data verification, site monitoring, adverse event reporting, and consent processes, under the regulatory framework of C.P. 7348.810. The inspection identified a primary violation, resulting in a one-item FDA Form 483 observation for "Inadequate Monitoring," specifically referencing 21 CFR 812.40. Dexcom failed to establish a defined monitoring frequency for study sites as required by their own standard operating procedures. Critically, for a majority of sites, the initial monitoring visit occurred only after all subjects had completed study procedures. This delay uncovered several significant protocol deviations post-completion, such as improper informed consent documentation, missed required testing (e.g., acetaminophen), subjects not adhering to protocol instructions, and unauthorized device removal. Dexcom's management acknowledged the findings and committed to implementing corrections. They indicated that a Corrective and Preventive Action (CAPA) related to monitoring frequency had already been initiated and promised a formal response to the agency within 15 days.