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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.