# FDA 483 - Dexcom, Inc. - June 14, 2024

Source: https://www.keypedia.com/records/483/dexcom-inc/c94d5943-2ff5-48bb-a14a-d4a3bae40b72

> FDA 483 for Dexcom, Inc. on June 14, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dexcom, Inc.
- Inspection Date: 2024-06-14
- Product Type: devices
- Office Name: Center for Drug Evaluation and Research
- Summary: During an inspection from June 10-14, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Dexcom, Inc., a medical device manufacturer located in Mesa, AZ. The inspection identified two significant observations concerning the company's quality system, specifically for its G6 and G7 Continuous Glucose Monitoring (CGM) systems.The first observation noted that process validation activities were not adequately documented. Inspectors found excessively wide allowable ranges for critical process control parameters in sensor dipping formulations, which could impact coating uniformity and sensor accuracy. Dexcom's own Process Engineering Director acknowledged that products manufactured at the extremes of these ranges would likely exhibit non-conformities. Additionally, internally developed calculators for process parameters lacked sufficient validation, and current in-process and finished product testing methods were deemed inadequate, particularly for verifying critical quality attributes like acetaminophen interference.The second observation highlighted deficiencies in Dexcom's corrective and preventive action (CAPA) procedures. An existing CAPA, initiated due to an increased complaint rate for CGM systems, contained corrective activities that were already implemented before the CAPA was created or expanded. Furthermore, a manufacturing method associated with inadequate material dissolution, identified as a root cause within this CAPA, continued to be used.These observations indicate potential non-compliance with established quality system requirements for medical device manufacturing. Dexcom, Inc. is required to submit a comprehensive response to the FDA outlining its corrective and preventive actions to address these findings.

## Related Documents

- [EIR - 2018-03-22](https://www.keypedia.com/records/eir/dexcom-inc/904a9525-4d87-4f21-b1ee-0fd944b0a770)
- [483 - 2024-11-07](https://www.keypedia.com/records/483/dexcom-inc/2f0ba24b-f828-47c6-ba05-48e551c1460e)
- [483 - 2024-06-14](https://www.keypedia.com/records/483/dexcom-inc/824f979d-c9ac-43cf-b495-716a7fe418b5)

## Related Officers

- [company_representative](https://www.keypedia.com/people/deanna-m-talerico/1e393883-43ef-40d6-92a5-868effd602ae)
- [FDA_PERSONNEL](https://www.keypedia.com/people/maida-henesian-investigator/42bff98f-2354-4a1e-8b7e-caea2b1fa43b)

Company: https://www.keypedia.com/companies/dexcom-inc/951d0c4e-48b6-4963-9475-c905cf7fbf75

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c