Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-14.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2020 – 14 Feb 2020 | Medical Devices & Rad Health | Clean | |
| 9 Dec 2015 – 23 Dec 2015 | Medical Devices & Rad Health | WL | View 483 → |
| 9 Apr 2014 – 2 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jun 2012 | Not recorded | Clean | |
| 26 Oct 2009 | Not recorded | 483 | View 483 → |
| 9 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Dec 2015
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Cynthia L Gorveatt
Investigators
FDA investigators tied to this site in the record.
Cynthia L Gorveatt2 insp.
Christopher S Genther1 insp.
Sharon I Gundersen1 insp.
Deborah A Nebenzahl1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cenorin, LLC'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