Dexcom, Inc.

Warning LetterOpen

Kevin R. Sayer CEO & President Dexcom, Inc. 6340 Sequence Drive San Diego , CA 92121 United States ksayer@dexcom.comFEI 3004753838Issued Mar 4, 2025Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004753838.

Letter Details

Firm: Dexcom, Inc.
Location: Kevin R. Sayer CEO & President Dexcom, Inc. 6340 Sequence Drive San Diego , CA 92121 United States ksayer@dexcom.com
FEI Number: 3004753838
Country: United States
Issue Date: March 04, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Dexcom, Inc. received a warning for manufacturing adulteration of its G6 and G7 continuous glucose monitors, which violated current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. FDA inspections at Dexcom's San Diego and Mesa facilities (June-November 2024) identified failures to establish proper procedures for monitoring and controlling process parameters for validated processes, specifically in functional acceptance testing that determines whether glucose sensors meet required specifications for glucose sensitivity slope, acetaminophen accuracy, and oxygen response. The company had submitted multiple responses to FDA's inspectional observations between July 2024 and January 2025 but apparently did not adequately correct the identified violations.