Overview
- 13 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-07.
At a glance
Inspections
13
Form 483s
7
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2024 – 7 Nov 2024 | Medical Devices & Rad Health | WL | View 483 → |
| 25 Sep 2023 – 29 Sep 2023 | Medical Devices & Rad Health | Clean | |
| 30 Aug 2021 – 17 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Feb 2018 – 16 Feb 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Mar 2016 – 29 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Apr 2015 – 21 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 30 Oct 2013 – 7 Nov 2013 | Medical Devices & Rad Health | WL | On file |
| 18 Jul 2012 | Not recorded | Clean | |
| 6 Oct 2010 | Not recorded | Clean | |
| 8 Feb 2010 | Not recorded | WL | On file |
| 10 Dec 2008 | Not recorded | 483 | View 483 → |
| 30 Jan 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Nov 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(c)
Design input - Lack of or inadequate procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
Investigators
FDA investigators tied to this site in the record.
Trudy R Papson3 insp.
Shaquenta Y Perkins2 insp.
James R Montero1 insp.
Mary A Millner1 insp.
Adam J Ruben1 insp.
Stephen R Souza1 insp.
Matthew M Vernon1 insp.
Andrea A Branche1 insp.
Ademola O Daramola1 insp.
Kimberly M Lichter1 insp.
Scott K Zika1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dexcom, Inc.'s 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat