Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-16.
At a glance
Inspections
12
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 16 Jan 2026 | Medical Devices & Rad Health | Clean | |
| 13 Feb 2025 – 20 Feb 2025 | Medical Devices & Rad Health | Clean | |
| 8 Aug 2022 – 12 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 7 Apr 2021 – 4 May 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jun 2018 – 29 Jun 2018 | Medical Devices & Rad Health | 483 | On file |
| 11 Aug 2014 – 22 Aug 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Dec 2012 | Not recorded | 483 | View 483 → |
| 9 Dec 2011 | Not recorded | Clean | |
| 15 Sep 2004 | Not recorded | Clean | |
| 22 Jan 2002 | Not recorded | Clean | |
| 1 Feb 2001 | Not recorded | Clean | |
| 27 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Dec 2012
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Sean T Creighton, Kelly D Sheppard
7 Dec 2012
21 CFR 820.30(f)
Design verification - documentation
Cited by Sean T Creighton, Kelly D Sheppard
7 Dec 2012
21 CFR 820.30(h)
Incorrect translation to production specifications
Cited by Sean T Creighton, Kelly D Sheppard
Investigators
FDA investigators tied to this site in the record.
Roy Baby1 insp.
Elizabeth A Krolczyk1 insp.
Andrea A Branche1 insp.
Ruth E Medcalf1 insp.
Jocelyn C Turner1 insp.
Terri E Gibson1 insp.
Ellen J Tave1 insp.
MDSAP harperd1 insp.
Phillip M Pontikos1 insp.
Daniel S Fam1 insp.
Sean T Creighton1 insp.
Kelly D Sheppard1 insp.
Iris C Macinnes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(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) | 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(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LivaNova USA, Inc.'s 4 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