Overview
- 24 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-10.
At a glance
Inspections
24
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2025 – 10 Feb 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Aug 2023 – 1 Sep 2023 | Medical Devices & Rad Health | Clean | |
| 29 Jan 2020 – 4 Feb 2020 | Medical Devices & Rad Health | Clean | |
| 25 Nov 2019 – 21 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 23 Apr 2018 – 14 May 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 6 Nov 2017 – 16 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 23 Aug 2017 – 30 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 23 Feb 2016 – 29 Feb 2016 | Medical Devices & Rad Health | Clean | |
| 16 Sep 2014 – 1 Oct 2014 | Human Drugs | 483 | On file |
| 3 Jun 2014 – 4 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 16 Oct 2013 – 31 Oct 2013 | Medical Devices & Rad Health | Clean | |
| 15 Aug 2013 – 25 Sep 2013 | Medical Devices & Rad Health | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2018
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Kyle J Mccracken, Susan M Matthias
14 May 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kyle J Mccracken, Susan M Matthias
14 May 2018
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Kyle J Mccracken, Susan M Matthias
Investigators
FDA investigators tied to this site in the record.
Ralph W Jerndal5 insp.
Sharon L Matson3 insp.
Melissa I Michurski3 insp.
Kyle J Mccracken2 insp.
Susan M Matthias2 insp.
Marissa S Steinhagen2 insp.
Aaron L Dunbar2 insp.
Tyler R Courtney1 insp.
Karen M Montgomery1 insp.
Joseph D Gong1 insp.
April L Young1 insp.
Marissa S Henning1 insp.
James A Beaulieu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | 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 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic, Inc.'s 5 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