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1066564

21st Century Scientific Inc — FEI 1000125727

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 12, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Coeur d Alene, ID (United States)

Facility

Other inspections at this facility

  • 1151898 (NAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007072 (NAI Tue Mar 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736167 (NAI Wed Jul 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 547939 (NAI Wed Oct 29 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
323621 CFR 820.72(b)Calibration procedures - content
323721 CFR 820.72(b)Remedial action
63021 CFR 803.17Lack of Written MDR Procedures