Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-13.
At a glance
Inspections
10
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jul 2022 – 13 Jul 2022 | Medical Devices & Rad Health | Clean | |
| 9 Sep 2020 – 22 Sep 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Jan 2017 – 3 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jan 2016 – 3 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2014 – 18 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Apr 2012 | Not recorded | 483 | View 483 → |
| 1 Aug 2011 | Not recorded | 483 | View 483 → |
| 26 Jan 2011 | Not recorded | 483 | View 483 → |
| 20 Dec 2007 | Not recorded | Clean | |
| 6 Aug 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Sep 2020
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Wendy M Stone, Sara M Onyango
22 Sep 2020
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Wendy M Stone, Sara M Onyango
22 Sep 2020
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Wendy M Stone, Sara M Onyango
Investigators
FDA investigators tied to this site in the record.
Nicholas C Mendiola5 insp.
Wendy M Stone2 insp.
Sara M Onyango1 insp.
Scott R Izyk1 insp.
Jeanette L Mcginnis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(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 ConMed Corporation'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