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Clinical pathology / Hygiene / Electron beam / Microbiology / Sterilization / Plasmapheresis / Apheresis / Sterility assurance level / Medicine / Transfusion medicine / Biology


DEPARTMENT OF HEALTH & HUMAN SERVICES U.S. 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

Maricao / /

Company

Submission Content Fenwal Inc. / NDA / Fenwal Inc. / /

Continent

Europe / /

Country

Puerto Rico / /

Event

FDA Phase / Reorganization / /

Facility

Puerto Rico plant / Puerto Rico manufacturing plant / PR plant / PR manufacturing plant / /

IndustryTerm

manufacturing facility / platelet storage solution / manufacturing conditions / blood-bank conditions / clinical data / plasma solution / manufacturing plant / solution drug products / product manufacturing / plastics / isotonic solution / final product / platelet product / manufacturing / blood storage solutions / drug products / /

MedicalCondition

sterility / /

MedicalTreatment

apheresis / /

Organization

U.S. Food and Drug Administration Center for Biologics Evaluation / Research office of Compliance / Compliance and Biologics Quality Division of Manufacturing and Product Quality To / FDA / European Union / DEPARTMENT OF HEALTH / /

Person

Randa Melhem / Chiang Syin / /

Position

Branch Chief / sterilizer / biological indicator bioburden model for sterilization processes / Executive / representative / /

Product

InterSol solution / InterSol / Europe / Sterile Products / /

Technology

process control / /

SocialTag