FDA Inspection
ConMed CorporationConMed Corporation – FDA Inspection, Feb 3, 2016
Record Details
This FDA Inspection record concerns ConMed Corporation, with an inspection on February 3, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ConMed Corporation
- Inspection Date
- February 3, 2016
- Product Type
- Devices
View Company Profile
ID · 206449f6-bd44-43b3-b752-f34220258fbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963326
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ConMed Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 22, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ConMed Corporation
- FDA Inspection 1175139 - 2022-07-13
- FDA Inspection 1129759 - 2020-09-22
- FDA Inspection 999612 - 2017-02-03
- FDA Inspection 890625 - 2014-07-18
- FDA Inspection 781540 - 2012-04-26
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.