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Childbirth / Blood banks / Hematology / Cord blood bank / Blood / Cord blood / Cell therapy / Blood donation / Cryopreservation / Biology / Stem cells / Anatomy


Memorandum Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality
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City

Durham / /

Company

Page 8 CCBB Processing Laboratory / Local Shipping / Potency Laboratory / Duke Hospital Stem Cell Laboratory / Floor Diagrams CCBB Processing Laboratory / CCBB Processing Laboratory / FedEx / Processing Laboratory / RAC / /

Facility

Laboratory Performin / Cord Blood Collection Site Memorial Hospital / Lake Boone Trail / Potency Laboratory / North Pavilion / Army Medical Center / Duke University North Pavilion Building / Suite (b)(4) laboratory / Rex Hospital / Women's Hospital / Building Durham / No. Function Processing Laboratory Duke University Hospital / Facility Reviewer / Duke Hospital Stem Cell Laboratory / Durham Regional Hospital / University of North CarolinaChapel Hill / North Pavilion Building / Regulatory Affairs Hock Plaza / Manning Drive Chapel / CCBB Processing Laboratory / Women's Hospital of Greensboro / /

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IndustryTerm

manufacturing step / collected site / collected cord blood products / storage equipment / collection site / manufacturing process / impermeable building materials / individual product / main manufacturing areas / overall manufacturing flow / /

MedicalCondition

Hurler Syndrome / Positive sterility / Krabbe Disease / Hematological malignancies / Sterility / Primary immunodeficiency Diseases / peroxisomal enzyme deficiency disorders / failed sterility / Globoid Leukodystrophy / product sterility / diseases / relevant communicable disease / /

MedicalTreatment

Cell Therapy / /

NaturalFeature

North CarolinaChapel Hill / /

Organization

Durham Regional Hospital / Food and Drug Administration Center for Biologics Evaluation / Duke BMT QA Committee / Laboratory Operations Supervisor Office / Air Handling Unit / Transplant Center / Laboratory Manager Office / Army Medical Center / Duke University / Women's Hospital / Duke University School of Medicine Vice / Duke University School of Medicine / University of North CarolinaChapel Hill / Research office of Compliance / Biologics Quality Division of Manufacturing and Product Quality To / Compliance and Biologics Quality Division of Manufacturing and Product Quality To / FDA / Rex Hospital / Cord Blood Collection Site Memorial Hospital / Women's Hospital of Greensboro / Product Office / /

Person

Cord Blood / Cord Blood Shipper / Nancy Waites / Carolyn Renshaw / Mark Davidson / Bruce Burnett / Nancy Andrews / /

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Position

Branch Chief / technician / Director / Regulatory Affairs / Chancellor for Academic Affairs / Chair / midwife / unit and activated temperature logger / /

Product

Dextrose / /

ProvinceOrState

North Carolina / /

RadioStation

CBU / /

Technology

Cell Therapy / transplantation / flash / /

SocialTag