FDA Inspection
Dexcom, Inc.Dexcom, Inc. – FDA Inspection, Nov 7, 2013
Record Details
This FDA Inspection record concerns Dexcom, Inc., with an inspection on November 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dexcom, Inc.
- Inspection Date
- November 7, 2013
- Product Type
- Devices
View Company Profile
ID · 5915f8ac-737d-4315-94dc-3c5d3ab2edea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 855467
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(b)Information used for annual reports
- 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 |
| March 29, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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 965585 - 2016-03-29
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