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1073344

Biomat USA, Inc — FEI 3004036082

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 3, 2018
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Arlington, TX (United States)

Facility

Other inspections at this facility

  • 1149030 (NAI Fri Jul 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984570 (NAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892304 (NAI Thu Aug 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783979 (NAI Wed Jun 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 654445 (NAI Fri Mar 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
905221 CFR 600.11(b)Equipment
907821 CFR 600.12(a)Maintenance - tracing
922521 CFR 606.171Biological product deviation report
924121 CFR 630.40(a)Supplemental results