Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-27.
At a glance
Inspections
11
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Aug 2025 – 27 Aug 2025 | Medical Devices & Rad Health | Clean | |
| 18 Jan 2024 – 9 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jun 2021 – 29 Jun 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Sep 2019 – 30 Sep 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Mar 2017 – 14 Mar 2017 | Medical Devices & Rad Health | Clean | |
| 10 May 2016 – 12 May 2016 | Medical Devices & Rad Health | 483 | On file |
| 30 Jan 2014 – 19 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Mar 2011 | Not recorded | 483 | View 483 → |
| 4 Feb 2010 | Not recorded | 483 | View 483 → |
| 20 Sep 2007 | Not recorded | Clean | |
| 30 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2024
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Christine I Shaw
9 Feb 2024
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Christine I Shaw
29 Jun 2021
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Christine I Shaw
Investigators
FDA investigators tied to this site in the record.
Janet Pulver2 insp.
Matthew M Vernon2 insp.
Christine I Shaw2 insp.
MDSAP harperd1 insp.
MDSAP WilliamsA1 insp.
Laura B Kennedy1 insp.
Amanda S Zorn1 insp.
Ashleigh P Wodushek1 insp.
Bryan J Love1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1040.10(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | 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 820.50 | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Navigation, 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