Overview
- 19 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-05.
At a glance
Inspections
19
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Apr 2023 – 5 May 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Oct 2022 – 3 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Aug 2021 – 9 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 19 Sep 2019 – 17 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jul 2019 – 6 Aug 2019 | Medical Devices & Rad Health | Clean | |
| 11 Jun 2018 – 21 Jun 2018 | Medical Devices & Rad Health | Clean | |
| 5 Jun 2017 – 30 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Aug 2015 – 26 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2013 – 19 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 14 Feb 2013 – 3 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 May 2012 | Not recorded | 483 | View 483 → |
| 20 Jul 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
5 May 2023
21 CFR 803.17(a)(1)
Lack of System for Event Evaluations
Cited by Christina L Bigham, Laiza V Garcia
5 May 2023
21 CFR 803.17(a)(1)
Lack of System for Event Evaluations
Cited by Christina L Bigham, Laiza V Garcia
5 May 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Christina L Bigham, Laiza V Garcia
Investigators
FDA investigators tied to this site in the record.
Susan M Matthias5 insp.
Joseph D Gong4 insp.
Christina L Bigham2 insp.
Marissa S Steinhagen2 insp.
April L Young2 insp.
Ralph W Jerndal2 insp.
Laiza V Garcia1 insp.
Tyler R Courtney1 insp.
Jennifer S Ness1 insp.
Mary A Millner1 insp.
Kyle J Mccracken1 insp.
Eric M Padgett1 insp.
Joey C West1 insp.
Sharon L Matson1 insp.
Jessica L Johnson1 insp.
Marissa S Henning1 insp.
Ryan J Benedict1 insp.
Marie A Fadden1 insp.
Yehualashe A Gessesse1 insp.
Jaclyn N Munsch1 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(a) | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(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(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 820.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Neuromodulation's 9 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