Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-25.
At a glance
Inspections
12
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 May 2026 – 25 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Mar 2025 – 16 Apr 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Mar 2023 – 13 Apr 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Feb 2018 – 16 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 13 Jan 2015 – 28 Jan 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Oct 2013 – 22 Oct 2013 | Medical Devices & Rad Health | Clean | |
| 25 Jan 2013 | Not recorded | Clean | |
| 20 Dec 2010 | Not recorded | 483 | View 483 → |
| 8 Mar 2010 | Not recorded | WL | View 483 → |
| 24 Jan 2008 | Not recorded | 483 | On file |
| 10 Jun 2003 | Not recorded | Clean | |
| 8 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jun 2026
ISO 13485:2016 Clause 6.4.2
Arrangements for control of contaminated product not planned and documented
Cited by Frank J Marciniak, Matthew W Kyle
25 Jun 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs do not include all requirements
Cited by Frank J Marciniak, Matthew W Kyle
25 Jun 2026
ISO 13485:2016 Clause 7.5.1
Production and service provision not adequate
Cited by Frank J Marciniak, Matthew W Kyle
25 Jun 2026
ISO 13485:2016 Clause 7.5.11
Procedures for preserving the conformity of product not documented
Cited by Frank J Marciniak, Matthew W Kyle
25 Jun 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Frank J Marciniak, Matthew W Kyle
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak4 insp.
Matthew W Kyle2 insp.
Monica L Gutierrez2 insp.
Kinh Q Mac2 insp.
Amy M Cramer1 insp.
Jonee J Mearns1 insp.
Sarah M Forney1 insp.
Stephanie Durso1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.11 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.3 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LeMaitre Vascular, 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