Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-06.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2026 – 6 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Nov 2022 – 10 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 16 Oct 2019 – 17 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 22 Oct 2014 – 18 Nov 2014 | Medical Devices & Rad Health | 483 | On file |
| 12 Aug 2013 – 20 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Apr 2012 | Not recorded | 483 | View 483 → |
| 27 Jan 2010 | Not recorded | Clean | |
| 10 Jun 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Apr 2026
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
21 CFR 830.310(b)
GUDID Information required for unique device identification.
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
ISO 13485:2016 Clause 7.3.1
Design and development procedures not documented
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
ISO 13485:2016 Clause 7.3.9
Procedures to control design and development changes not documented
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Matthew M Vernon, Patrick D Galdun
Investigators
FDA investigators tied to this site in the record.
Janet Pulver3 insp.
Matthew M Vernon1 insp.
Patrick D Galdun1 insp.
Christine I Shaw1 insp.
Vicky L Cruz1 insp.
Thai T Duong1 insp.
Amanda S Zorn1 insp.
Debra L Curtis1 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 | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1002.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.310(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ConMed Corporation'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