Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-16.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 May 2023 – 16 May 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 May 2022 – 15 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jul 2021 | Biologics | Clean | |
| 25 Aug 2020 – 27 Aug 2020 | Medical Devices & Rad Health | Clean | |
| 27 Jul 2017 – 1 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 25 Feb 2013 – 4 Mar 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Feb 2012 | Not recorded | Clean | |
| 2 Mar 2010 | Not recorded | Clean | |
| 5 Feb 2008 | Not recorded | 483 | On file |
| 6 Mar 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jun 2022
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Nabil Nakhoul, Diane M Biron
15 Jun 2022
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Nabil Nakhoul, Diane M Biron
Investigators
FDA investigators tied to this site in the record.
Nabil Nakhoul3 insp.
Sunita Pandey1 insp.
Diane M Biron1 insp.
Alice C Silva1 insp.
Laurie B Frazier1 insp.
Camerson E Moore1 insp.
Matthew C Watson1 insp.
M. P Murphy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LeMaitre Vascular, 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