FDA Inspection
Dexcom, Inc.Dexcom, Inc. – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Dexcom, Inc., with an inspection on February 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e2472c3d-9870-4181-b652-d7105450f55b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041434
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dexcom, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Medical Devices |
| September 29, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 17, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dexcom, Inc.
- FDA Inspection 1250922 - 2024-11-07
- FDA Inspection 1220386 - 2023-09-29
- FDA Inspection 1152320 - 2021-09-17
- FDA Inspection 965585 - 2016-03-29
- FDA Inspection 923017 - 2015-04-21
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