FDA WARNING_LETTER - Dexcom, Inc. - November 07, 2024

The FDA issued a Warning Letter to a firm manufacturing G6 and G7 continuous glucose monitors following inspections in San Diego, CA (Oct-Nov 2024) and Mesa, AZ (June 2024). The devices were deemed adulterated under 21 U.S.C. § 351(h) for non-conformity with Quality System regulation (21 CFR Part 820).

Violations include: 1. **Failure to control process parameters (21 CFR 820.75(b)):** Inadequate monitoring of glucose and acetaminophen concentrations during functional acceptance testing. The firm's health hazard assessment and acetaminophen specification assessment were deemed inadequate. 2. **Failure to validate processes (21 CFR 820.75(a)):** Test method validation for the (b)(4) System lacked documentation of measured results, and measurement uncertainty was not incorporated into acceptance criteria. Manufacturing specifications for glucose concentration were not validated. 3. **Inadequate design input procedures (21 CFR 820.30(c)):** Failure to define all special control requirements for manufacturing controls and acceptance criteria, and lack of documented requirements for the expected lifetime sensitivity of sensors. The firm's MARD specification and M0/Mf specifications were questioned. 4. **Inadequate design change procedures (21 CFR 820.30(i)):