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966729

ACell, Inc — FEI 3005920706

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 8, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Columbia, MD (United States)

Facility

Other inspections at this facility

  • 856079 (NAI Wed Nov 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 811984 (OAI Thu Dec 20 2012 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
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures