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595748

Biomat USA Inc. DBA Talecris Plasma Resources — FEI 3003794683

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 19, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Milwaukee, WI (United States)

Facility

Other inspections at this facility

  • 1063663 (NAI Thu Jul 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977714 (NAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888029 (NAI Thu Jul 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 761070 (NAI Fri Dec 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 672387 (NAI Tue Jul 13 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
14321 CFR 606.140(b)Provisions to monitor lab test procedures & instruments
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs