FDA Inspection 913301 — Wilson-Cook Medical Inc.

Wilson-Cook Medical Inc. — FEI 1037905

The FDA completed an inspection of Wilson-Cook Medical Inc. on December 23, 2014 in Winston Salem, NC. 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
December 23, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Winston Salem, NC (United States)

Citations

IDCFRDescription
369621 CFR 820.100(b)Documentation
419221 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))