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709427

Cranial Solutions — FEI 3003524425

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 21, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Pompton Lakes, NJ (United States)

Facility

Other inspections at this facility

  • 1029549 (NAI Mon Sep 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 778684 (NAI Fri Apr 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 662534 (OAI Fri May 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
337521 CFR 820.198(e)Records of complaint investigation
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
405921 CFR 820.22Quality Audits - defined intervals