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709983

Capco Custom Packaging Inc — FEI 3002985640

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 10, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tempe, AZ (United States)

Facility

Other inspections at this facility

  • 1070520 (NAI Tue Sep 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944218 (NAI Wed Sep 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 846382 (NAI Fri Aug 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782537 (OAI Fri May 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 641512 (VAI Mon Feb 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191221 CFR 211.166(a)Written program not followed
200921 CFR 211.188Prepared for each batch, include complete information
203121 CFR 211.194(a)Complete test data included in records
359221 CFR 211.110(c)In-process materials characteristics testing
360321 CFR 211.160(b)Scientifically sound laboratory controls
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
439121 CFR 211.180(e)(2)Items to cover on annual reviews