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1027037

Isopure Corp. — FEI 3013942511

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 28, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Louisville, KY (United States)

Facility

Other inspections at this facility

  • 1246559 (VAI Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1187429 (NAI Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102484 (VAI Mon Sep 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 741461 (VAI Thu Aug 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation