FDA 483 - Dexcom, Inc. - November 07, 2024

**FDA 483 Summary for Dexcom, Inc.**

**Company Name:** Dexcom, Inc.

**Inspection Dates:** Not specified in the provided text.

**Main Violations/Issues:** 1. **Glucose Sensor Testing:** Dexcom's system for testing glucose sensors, particularly the G6 model, has inadequate procedures for maintaining consistent glucose concentrations in test dishes. This inconsistency arises due to factors like evaporation and physical loss, which are not sufficiently monitored or controlled.

2. **Acetaminophen Concentration:** There is a need for improved monitoring of acetaminophen concentrations in test solutions, as fluctuations could affect sensor accuracy.

3. **Validation of Testing System:** The validation process for the system used in functional acceptance testing of glucose sensors is insufficient. The test method validation did not adequately ensure the system's reliability, as evidenced by inconsistent testing results.

**Regulatory Framework:** The observations are based on FDA's Good Manufacturing Practice (GMP) regulations, which require consistent monitoring and validation of testing processes to ensure product safety and efficacy.

**Required Actions:** - **Corrective and Preventive Actions (CAPA):** Dexcom initiated CAPA-000462 to address the root causes identified in the FDA's observations. This includes implementing additional monitoring of glucose concentrations and studying acetaminophen concentration changes.

- **Monitoring and Testing Adjustments:** Dexcom has begun lot monitoring of glucose concentrations and validated a new test method for acetaminophen concentration measurement. These actions aim to ensure that solution concentrations remain within specified limits.

- **Process Documentation Updates:** The company plans to update its Process Failure Mode and Effects Analysis (FMEA) to better document potential risks and mitigations. Additionally, Dexcom will revise its equipment and process qualification procedures to incorporate identified controls into process validation and risk management.

**Completion Dates:** Key corrective actions are scheduled for completion between November 12, 2024, and December 1, 2024.

Dexcom is actively addressing the FDA