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1015917

Optikem International, Inc. — FEI 1720129

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 3, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Denver, CO (United States)

Facility

Other inspections at this facility

  • 1231534 (OAI Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1174263 (VAI Mon Jul 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036150 (VAI Mon Dec 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 650470 (NAI Thu Mar 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
315921 CFR 820.184DHR content
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
54621 CFR 820.75(a)Lack of or inadequate process validation