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930427

Innovative Transfusion Medicine, Inc. — FEI 3000207042

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 16, 2015
Fiscal Year
2015
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))
  • 1102613 (VAI Thu Sep 19 2019 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))

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
15421 CFR 606.160(a)(1)Concurrent documentation
6121 CFR 606.60(a)Provide proper equipment to meet requirements
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
924321 CFR 630.40(a)Notification
926621 CFR 610.40(e)Further testing
926921 CFR 610.40(h)Shipment/use of reactive units, units from deferred donors
927021 CFR 610.40(h)(2)(ii)Labeling of reactive units, units from deferred donors