Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-31.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2024 – 31 Oct 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Oct 2016 – 27 Oct 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Aug 2013 – 15 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 16 Dec 2011 | Not recorded | Clean | |
| 10 Dec 2009 | Not recorded | 483 | View 483 → |
| 12 Jun 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Oct 2016
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Catherine J Laufmann
27 Oct 2016
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Catherine J Laufmann
Investigators
FDA investigators tied to this site in the record.
Felix J Marrero1 insp.
Catherine J Laufmann1 insp.
Andrew A Leboeuf1 insp.
Yehualashe A Gessesse1 insp.
Tania E Vizcaino1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic CryoCath LP's 3 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