Overview
- 21 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-23.
At a glance
Inspections
21
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Oct 2025 – 23 Oct 2025 | Medical Devices & Rad Health | WL | View 483 → |
| 6 Nov 2023 – 16 Nov 2023 | Medical Devices & Rad Health | Clean | |
| 11 Apr 2022 – 21 Apr 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Apr 2021 – 29 Apr 2021 | Medical Devices & Rad Health | Clean | |
| 16 Jul 2018 – 19 Jul 2018 | Medical Devices & Rad Health | Clean | |
| 28 Nov 2017 – 4 Dec 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Oct 2017 – 13 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 18 Oct 2016 – 21 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 7 Mar 2016 – 10 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 7 Oct 2015 – 22 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jan 2014 – 7 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 9 May 2013 – 31 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Oct 2025
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Suyang Qin, Marlo-Ian M Alintanahin
23 Oct 2025
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Suyang Qin, Marlo-Ian M Alintanahin
21 Apr 2022
21 CFR 820.198(c)
Investigation of device failures
Cited by Maida Henesian, Katlin N Stubbs
Investigators
FDA investigators tied to this site in the record.
Maida Henesian4 insp.
MDSAP WilliamsA2 insp.
Jocelyn T Ramos2 insp.
Suyang Qin1 insp.
Marlo-Ian M Alintanahin1 insp.
Alexandria L Capuano1 insp.
Katlin N Stubbs1 insp.
Elizabeth A Dakan1 insp.
Joan T Briones1 insp.
Thea C Grome1 insp.
Quynh Strandberg1 insp.
Linda Linh T Nguyen1 insp.
Juan A Morales1 insp.
Lydia S Chan1 insp.
Sergio Chavez1 insp.
Cindy W Lewis1 insp.
Mark E Chan1 insp.
Alla Dubrovsky1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbott Diabetes Care, 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