FDA Inspection
Dexcom, Inc.Dexcom, Inc. – FDA Inspection, Nov 7, 2024
Record Details
This FDA Inspection record concerns Dexcom, Inc., with an inspection on November 7, 2024, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 6f6155e1-7e42-4c29-b575-fd65eb84e9fa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1250922
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
7- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Dexcom, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| April 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dexcom, Inc.
- FDA Inspection 1220386 - 2023-09-29
- FDA Inspection 1152320 - 2021-09-17
- FDA Inspection 1041434 - 2018-02-16
- FDA Inspection 965585 - 2016-03-29
- FDA Inspection 923017 - 2015-04-21
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