FDA Inspection
Dexcom, Inc.Dexcom, Inc. – FDA Inspection, Mar 29, 2016
Record Details
This FDA Inspection record concerns Dexcom, Inc., with an inspection on March 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dexcom, Inc.
- Inspection Date
- March 29, 2016
- Product Type
- Devices
View Company Profile
ID · 7fb828e6-b61a-4d4b-85e5-12fcf3a495c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965585
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
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 |
| February 16, 2018 | 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 1041434 - 2018-02-16
- FDA Inspection 923017 - 2015-04-21
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