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697740

Biomat USA, Inc. — FEI 1572453

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Farmington Hills, MI (United States)

Facility

Other inspections at this facility

  • 1068977 (NAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 869867 (NAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800223 (NAI Fri Sep 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 552512 (VAI Fri Dec 12 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
16521 CFR 606.170(a)Adverse reaction - Maintenance of Reports
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration