FDA Inspection 739936 — ConMed Corporation

ConMed Corporation — FEI 3001451571

The FDA completed an inspection of ConMed Corporation on August 1, 2011 in Utica, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 1, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Utica, NY (United States)

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310421 CFR 820.30(j)Design history file