Overview
- 16 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
16
Form 483s
8
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 6 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 1 May 2017 – 3 May 2017 | Medical Devices & Rad Health | 483 | On file |
| 26 Apr 2016 – 28 Apr 2016 | Medical Devices & Rad Health | 483 | On file |
| 2 Nov 2015 – 5 Nov 2015 | Medical Devices & Rad Health | Clean | |
| 26 Oct 2015 – 3 Nov 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Oct 2015 – 23 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Mar 2014 – 11 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jul 2013 – 15 Jul 2013 | Medical Devices & Rad Health | Clean | |
| 6 Jun 2012 | Not recorded | 483 | View 483 → |
| 6 Aug 2010 | Not recorded | 483 | On file |
| 4 Mar 2010 | Not recorded | Clean | |
| 25 Feb 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Nov 2015
21 CFR 812.150(b)(10)
No sponsor report in response to a request
Cited by Barbara D Wright, Konsuela Y Glass
3 Nov 2015
21 CFR 812.40
Sponsors' general responsibilities
Cited by Barbara D Wright, Konsuela Y Glass
23 Oct 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Shayla G Turnipseed, Bonnie E Conley, Bonnie E Pierson
23 Oct 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Shayla G Turnipseed, Bonnie E Conley, Bonnie E Pierson
23 Oct 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Shayla G Turnipseed, Bonnie E Conley, Bonnie E Pierson
Investigators
FDA investigators tied to this site in the record.
MDSAP WilliamsA2 insp.
Bonnie E Conley2 insp.
Bonnie E Pierson2 insp.
Wendy R Blame2 insp.
Thomas O Morgan2 insp.
Laura L Staples1 insp.
Kellie R Riggs1 insp.
Natasha N Mccants1 insp.
Barbara D Wright1 insp.
Konsuela Y Glass1 insp.
Shayla G Turnipseed1 insp.
Francis A Guidry1 insp.
Jessica Stephens1 insp.
Brian S Lynch1 insp.
Erica M Katherine1 insp.
Travis E Chapman1 insp.
Christophe L Boulmay1 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 812.150(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | 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(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | 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(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Sofamor Danek USA 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