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650470

Optikem International, Inc. — FEI 1720129

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 11, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 1015917 (VAI Wed May 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
323621 CFR 820.72(b)Calibration procedures - content
369621 CFR 820.100(b)Documentation
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation