FDA Inspection 1117394 — Caution Wear Corporation

Caution Wear Corporation — FEI 3004819929

The FDA completed an inspection of Caution Wear Corporation on January 10, 2020 in Nashua, NH. 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
January 10, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Nashua, NH (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures