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1066151

American IV Products, Inc. — FEI 1121996

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 12, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Harmans, MD (United States)

Facility

Other inspections at this facility

  • 1246121 (VAI Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987959 (NAI Wed Oct 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874152 (NAI Wed Apr 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 734086 (NAI Wed Jul 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 672266 (NAI Wed Jul 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
311721 CFR 820.70(i)Software validation for automated processes
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
54621 CFR 820.75(a)Lack of or inadequate process validation