FDA 483 - Dexcom, Inc. - June 14, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Dexcom, Inc. in Mesa, AZ, was inspected regarding its G6 and G7 Continuous Glucose Monitoring (CGM) sensors. The inspection revealed significant issues with inadequate documentation of process validation activities for sensor dipping formulations, including overly wide parameter ranges and insufficient verification of critical quality attributes. Additionally, the firm's corrective and preventive action procedures were found to be inadequately established, with several CAPA activities implemented prior to the CAPA creation or scope expansion.
ID · 824f979d-c9ac-43cf-b495-716a7fe418b5