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Pharmaceutical sciences / Clinical research / Safety / Baxter International / Form FDA 483 / Chinese heparin adulteration / Heparins / Glycosaminoglycans / Food and Drug Administration


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Company

Baxter Healthcare Corporation / CNN / /

Country

United States / China / /

Event

Product Issues / Product Recall / /

Facility

FDA’s Center / Chanzhou SPL facility / /

IndustryTerm

manufacturing facility / sodium products / asked healthcare professionals / dilute solution / source manufacturer / manufacturing process / manufacturing capacity / media organization / intravenous solution / healthcare professionals / active pharmaceutical ingredient / active pharmaceutical ingredient source / inspectional work product / manufacturing / credentialed media / vial products / drug products / /

MedicalCondition

severe hypotension / blood clots / low blood pressure / /

Organization

office of New Drugs / office of Compliance / office of Regulatory Affairs / U.S. Food and Drug Administration / FDA’s Center for Drug Evaluation and Research / Office of Compliance at FDA’s Center for Drug Evaluation and Research / Office of New Drugs in FDA’s Center for Drug Evaluation and Research / /

Person

Karen Riley / Michael Rogers / Miriam Falco / Sandy Kweder / Murray Lumpkin / Deborah Autor / Sandra Kweder / /

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Position

EST Coordinator / Director of the Division / conference coordinator / Deputy Commissioner for International and Special Programs / Coordinator / Deputy Director / Director / reporter / /

Product

HepLock / Heparin Flush / Heparin / Baxter Heparin / Baxter Healthcare Corporation’s expanded / Heparin sodium / /

Technology

API / /

SocialTag