FDA Inspection 993664 — Criterion Tool & Die Inc

Criterion Tool & Die Inc — FEI 1000136409

The FDA completed an inspection of Criterion Tool & Die Inc on November 9, 2016 in Brookpark, 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
November 9, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Brookpark, OH (United States)

Citations

IDCFRDescription
312321 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
312721 CFR 820.80(e)Documentation