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811984

ACell, Inc — FEI 3005920706

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 20, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Columbia, MD (United States)

Facility

Other inspections at this facility

  • 966729 (NAI Tue Mar 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856079 (NAI Wed Nov 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 643284 (NAI Wed Feb 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
73121 CFR 803.50(a)(1)Report of Death or Serious Injury