FDA Inspection 970518 — Codonics Inc

Codonics Inc — FEI 1000639866

The FDA completed an inspection of Codonics Inc on April 15, 2016 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 15, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Cleveland, OH (United States)

Citations

IDCFRDescription
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures