FDA Inspection 890625 — ConMed Corporation

ConMed Corporation — FEI 3001451571

The FDA completed an inspection of ConMed Corporation on July 18, 2014 in Utica, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Utica, NY (United States)

Citations

IDCFRDescription
323521 CFR 820.72(a)Equipment control activity documentation
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures