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Pharmaceutical sciences / Center for Biologics Evaluation and Research / Form FDA 483 / Good manufacturing practice / Biologic / Quality management system / Office of Regulatory Affairs / Title 21 of the Code of Federal Regulations / Limulus amebocyte lysate / Food and Drug Administration / Medicine / Health


Compliance Program Guidance Manual
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City

Rockville / /

Company

CBER / /

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Event

FDA Phase / Reorganization / Product Issues / Product Recall / /

Facility

Laboratory Tests The Quality System / Rockville Pike / /

IndustryTerm

certain medical devices / biological products / bulk manufacturers / biological product manufacturers / blood bank / medical devices / blood products / blood banking practices / biological product / licensed manufacturers / manufacturing / manufacturing procedures / cellular and tissue-based products / /

MedicalCondition

TB / HIV / Hepatitis B / communicable disease / /

MedicalTreatment

Plasmapheresis / /

Organization

Compliance Program Guidance Manual Chapter / Division of Inspections and Surveillance / office of Compliance and Biologics Quality / Division of Domestic Field Investigations / Biologics Quality / Division of Inspections & Surveillance / Center for Devices and Radiological Health / office of Compliance / Product Quality / US FDA Office / Program Guidance Manual Chapter / Radiological Health / FDA / OCBQ’s Division of Manufacturing and Product Quality / Public Health Service / Regulatory Affairs/ office of Regional Operations Division of Domestic Field Investigations / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / OCBQ’s Division of Manufacturing / HFM-650 office of Compliance / Center for Devices / /

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Position

investigator / program specialist / TB investigator / TB supervisor / compliance officer / ORA/OE Compliance Officer / inspector / appropriate product specialist / product specialist / specialist / General / /

Product

Review of MDRs / Federal Food / IVDs supplement / /

ProvinceOrState

Maryland / /

SocialTag