FDA Inspection 911600 — iScreen Vision, Inc.

iScreen Vision, Inc. — FEI 3003004358

The FDA completed an inspection of iScreen Vision, Inc. on January 28, 2015 in Cordova, TN. 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
January 28, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Cordova, TN (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements