Thank you for the opportunity to respond to case # [redacted] , we take these concerns seriouslyGrifols is a major manufacturer of life-saving plasma therapies produced from donations of human plasma that are used to treat small, chronically-ill patient populationsWe operate plasma donor centers across the country that are highly regulated by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other domestic and international authoritiesFurthermore, Grifols adheres to voluntary standards that go over and above current regulatory requirementsThe International Quality Plasma Program (IQPP) and the Quality Standards of Excellence Assurance and Leadership (QSEAL) set forth requirements governing donor acceptance and exclusion criteria in addition to those mandated by regulatory bodiesAdherence to this wide range of criteria demonstrates Grifols' willingness to embrace the highest standards to help assure the health of our donors and the quality of our plasma medicinesGrifols is required by FDA to follow regulations governing plasma donor screening and qualificationsThe FDA Code of Federal Regulations Title Secoutlines donor suitability that all individuals are required to meet prior to donationGrifols remains steadfast in our commitment to the highest standards of plasma quality and safety of our donors and employeesIf you have any questions please do not hesitate to contact me or if you would like to learn more about Grifols go to www.grifolsplasma.com Biomat USA, IncCenter Manager, Richmond VA [redacted]
Thank you for the opportunity to respond to case # [redacted] , we take these concerns seriouslyGrifols is a major manufacturer of life-saving plasma therapies produced from donations of human plasma that are used to treat small, chronically-ill patient populationsWe operate plasma donor centers across the country that are highly regulated by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other domestic and international authoritiesFurthermore, Grifols adheres to voluntary standards that go over and above current regulatory requirementsThe International Quality Plasma Program (IQPP) and the Quality Standards of Excellence Assurance and Leadership (QSEAL) set forth requirements governing donor acceptance and exclusion criteria in addition to those mandated by regulatory bodiesAdherence to this wide range of criteria demonstrates Grifols' willingness to embrace the highest standards to help assure the health of our donors and the quality of our plasma medicinesGrifols is required by FDA to follow regulations governing plasma donor screening and qualificationsThe FDA Code of Federal Regulations Title Secoutlines donor suitability that all individuals are required to meet prior to donationGrifols remains steadfast in our commitment to the highest standards of plasma quality and safety of our donors and employeesIf you have any questions please do not hesitate to contact me or if you would like to learn more about Grifols go to www.grifolsplasma.com Biomat USA, IncCenter Manager, Richmond VA [redacted]