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547939

21st Century Scientific Inc — FEI 1000125727

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 29, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 1066564 (VAI Wed Sep 12 2018 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))

Recent compliance actions

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
342621 CFR 820.50(a)(1)Documented evaluation
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
405921 CFR 820.22Quality Audits - defined intervals