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1102613

Innovative Transfusion Medicine, Inc. — FEI 3000207042

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Miami Lakes, FL (United States)

Facility

Other inspections at this facility

  • 1242579 (VAI Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172604 (VAI Fri Jun 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010652 (VAI Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981304 (VAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951274 (VAI Tue Dec 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
1809721 CFR 630.10(h)Ineligible Donor
3121 CFR 606.20(b)Qualifications of responsible personnel
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs