FDA Inspection
ConMed CorporationConMed Corporation – FDA Inspection, Apr 6, 2012
Record Details
This FDA Inspection record concerns ConMed Corporation, with an inspection on April 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ConMed Corporation
- Inspection Date
- April 6, 2012
- Product Type
- Devices
View Company Profile
ID · 9433f9fb-8501-48f6-8458-d5104551315f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776015
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ConMed Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2026 | Not classified | Denver District Office | Compliance: Devices |
| November 10, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 20, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ConMed Corporation
- FDA Inspection 1311030 - 2026-04-06
- FDA Inspection 1190644 - 2022-11-10
- FDA Inspection 1108407 - 2019-10-17
- FDA Inspection 903998 - 2014-11-18
- FDA Inspection 849346 - 2013-09-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.