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1269870

Cranial Technologies, Inc — FEI 3000215614

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 13, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Chandler, AZ (United States)

Facility

Other inspections at this facility

  • 1024145 (NAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 838816 (VAI Wed Jun 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752831 (VAI Fri Nov 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
323121 CFR 820.70(i)Documentation of software validation
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures