FDA Inspection
Linvatec Corp. dba ConMed LinvatecLinvatec Corp. dba ConMed Linvatec – FDA Inspection, Mar 26, 2009
Record Details
This FDA Inspection record concerns Linvatec Corp. dba ConMed Linvatec, with an inspection on March 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 26, 2009
- Product Type
- Devices
View Company Profile
ID · 462c332e-8188-474d-83bb-0083dc334572
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 571631
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Linvatec Corp. dba ConMed Linvatec
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2026 | Not classified | Florida District Office | Compliance: Medical Devices |
| December 14, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2017 | Not classified | Florida District Office | |
| August 6, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 25, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Linvatec Corp. dba ConMed Linvatec
- FDA Inspection 1309064 - 2026-03-24
- FDA Inspection 1226977 - 2023-12-14
- FDA Inspection 1053500 - 2017-11-03
- FDA Inspection 843245 - 2013-08-06
- FDA Inspection 716814 - 2011-03-25
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