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FDA Inspection 1311030 — ConMed Corporation

ConMed Corporation — FEI 3004491689

The FDA completed an inspection of ConMed Corporation on April 6, 2026 in Greenwood Village, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Greenwood Village, CO (United States)

Citations

IDCFRDescription
2280121 CFR 830.310(b)GUDID Information required for unique device identification.
23098ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
23130ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
23215ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
23258ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
419221 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))

Facility

Other inspections at this facility

  • 1190644 (NAI Thu Nov 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108407 (NAI Thu Oct 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 903998 (NAI Tue Nov 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 849346 (VAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 776015 (VAI Fri Apr 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources