FDA Inspection
ConMed CorporationConMed Corporation – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns ConMed Corporation, with an inspection on February 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 80826560-c04f-4d7c-a4a6-d5bb1db7491c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999612
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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, 2016 | 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 963326 - 2016-02-03
- FDA Inspection 890625 - 2014-07-18
- FDA Inspection 781540 - 2012-04-26
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