Overview
- 20 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-03.
At a glance
Inspections
20
Form 483s
8
EIRs
9
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jan 2024 – 3 Jan 2024 | Medical Devices & Rad Health | Clean | |
| 21 Feb 2023 – 10 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jun 2021 – 7 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Mar 2020 – 2 Apr 2020 | Medical Devices & Rad Health | 483 | On file |
| 12 Feb 2019 – 15 Feb 2019 | Medical Devices & Rad Health | Clean | |
| 14 Feb 2018 – 14 Mar 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jul 2017 – 14 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 7 Mar 2017 – 24 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Jul 2016 – 22 Jul 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2014 – 21 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 5 Dec 2013 – 16 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2013 – 12 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Stephen R Souza, Matthew M Vernon, Elizabeth A Dakan
10 Mar 2023
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Stephen R Souza, Matthew M Vernon, Elizabeth A Dakan
10 Mar 2023
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Stephen R Souza, Matthew M Vernon, Elizabeth A Dakan
Investigators
FDA investigators tied to this site in the record.
Donna L Besone3 insp.
Janet Pulver2 insp.
Leonard H Lavi2 insp.
Sarah A Hassas2 insp.
Kelvin Cheung2 insp.
James R Fleckenstein2 insp.
Cheron M Portee1 insp.
Stephen R Souza1 insp.
Matthew M Vernon1 insp.
Elizabeth A Dakan1 insp.
MDSAP harperd1 insp.
Lakecha N Lewis1 insp.
Durell L Giles1 insp.
Uttaniti Limchumroon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic MiniMed, Inc.'s 8 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