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1118178

New York Blood Center Enterprises — FEI 2473015

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2020
Fiscal Year
2020
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Rye, NY (United States)

Facility

Other inspections at this facility

  • 1283668 (VAI Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1217513 (NAI Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209368 (VAI Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168524 (NAI Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064704 (NAI Tue Aug 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls