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1219047

iScreen Vision, Inc. — FEI 3003004358

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 28, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cordova, TN (United States)

Facility

Other inspections at this facility

  • 911600 (NAI Wed Jan 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760707 (VAI Wed Dec 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 551252 (NAI Tue Dec 02 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
320121 CFR 820.40(a)Not approved or obsolete document retrieval
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements