Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-11.
At a glance
Inspections
10
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2024 – 11 Jul 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Aug 2020 – 26 Feb 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 May 2016 – 29 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Jul 2013 – 16 Oct 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jun 2012 | Not recorded | 483 | View 483 → |
| 1 Apr 2011 | Not recorded | 483 | View 483 → |
| 14 May 2010 | Not recorded | WL | View 483 → |
| 17 Apr 2009 | Not recorded | 483 | On file |
| 25 Oct 2006 | Not recorded | Clean | |
| 14 Jul 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2024
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 803.56
Submission of Supplement to Individual Report Within One Month
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
Investigators
FDA investigators tied to this site in the record.
Kristen E Rescigno4 insp.
Frank J Marciniak3 insp.
Colin E Tack2 insp.
Melissa A Zuppe1 insp.
Monica L Gutierrez1 insp.
Melissa A Freeman1 insp.
Steven M Weinman1 insp.
Charles Chacko1 insp.
Doreen P Gubbay1 insp.
David H Smith1 insp.
Lauren L Vajo1 insp.
Kinh Q Mac1 insp.
Robert G Ruff1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 17x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Maquet Cardiovascular, LLC'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