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981304

Innovative Transfusion Medicine, Inc. — FEI 3000207042

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 8, 2016
Fiscal Year
2016
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))
  • 951274 (VAI Tue Dec 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220321 CFR 606.170(a)Adverse Reaction- Reports of Investigations
1808021 CFR 630.10(e)Medical History Interview
1809621 CFR 630.10(g)(2)(ii)Donor's Acknowledgment - Exculpatory language
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs