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City Triangle Park / / Company Esra Toussaint Lot Release Review Software / Determination Pass Pass Pass Establishment Description Avioq Inc. / Facility Inspection Avioq Inc. / Avioq Inc. / Ortho-Clinical Diagnostics / bioMerieux Inc. / M.D. / / Continent Africa / / Country Japan / United States / / Event Force Majeure / FDA Phase / Company Expansion / M&A / Product Issues / / Facility NC facility / Hospital Patientsb HTLV-I HTLV-II / Avioq facility / / IndustryTerm manufacturing activities / test equipment / licensed product / manufacturing processes / gene products / or manufacturing any other products / sulfuric acid solution / manufacturing equipment / infected cellular blood products / manufacturing / software changes / / MedicalCondition hairy cell leukemia / Tropical Spastic Paraparesis / Nasopharyngeal Lymphoma HTLV-I / II Adult T-Cell Leukemia HTLV-I / lymphoma / multiple myeloma / HTLV disease / chronic lymphocytic leukemia / arthritis / HTLV-I infection / observations HTLV-II infection / related diseases / neurologic disorder / Kaposi’s sarcoma / leukopenic chronic T-cell leukemia / Tropical Spastic Paraparesis HTLV-I / mycosis fungoides / strongyloidiasis / HTLV-II infections / chronic neurodegenerative diseases / HTLV-II infection / large granular lymphocyte leukemia / T-prolymphocytic leukemia / spastic ataxia / HCV / myelopathy / HTLV-I Associated Myelopathy / Adult T-Cell Leukemia / disorders / polymyositis / uveitis / / Organization Approval Office Signatory Authority / Quality Control / FDA / DEPARTMENT OF HEALTH AND HUMAN SERVICES / FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Summary Basis for Regulatory Action Date / Division of Biological Standards and Quality Control / / Person Aaron Diane Gubernot Labeling / Deborah Trout / Pradip Akolkar / Jay S. Epstein / Jennifer Schmidt / Dana Martin / Lot Release / / Position Director / OBRR /CBER Signatory Authorities Action / / Product sodium chloride / gentamicin sulfate / needles / Vironostika® HTLV / HTLV ORTHO® Assay / Avioq / syringes / / ProvinceOrState Quebec / North Carolina / / Region Caribbean / Southern Japan / / SportsEvent NHL / / Technology antibodies / / SocialTag 
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Summary Basis for Regulatory Action