Plasma, Inc.

Thank you for the opportunity to respond to case #***, 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 populations. We 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 authorities. Furthermore, 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 medicines. Grifols 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 donation. Grifols 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, Inc. Center Manager, Richmond VA ***

Revdex.com:
I have reviewed the offer and/or response made by the business in reference to complaint ID ***, and have determined that this proposed action would not resolve my complaint. For your reference, details of the offer I reviewed appear below
[Provide details of why you are not satisfied with this resolution.]
Regards,
*** ***
Hello,I reviewed the email sent to me,I do not have a problem with the screening process,my issue is with the unexplainations that I were not given.All I was told was that I could not donate,no one explained to me why.I would just have to keep coming back until I guess I was able to donate.That was not proper protocol,I was suppose to get a detailed explanation of why my results came back the way that they did.I really do believe that this is a further issue that needs to be looked into.Maybe the nurse should had explained to me but they did not,they just kept asking me if I wanted to take another sample.Well,maybe when I go back for my next lab test sample results they will know what they need to do as far as telling the donor all of the details and things that they need to know if it has to do with there health

Thank you for the opportunity to respond to case #[redacted], we take these concerns seriously. Grifols is a major manufacturer of life-saving plasma therapies produced from donations of human plasma that are used to treat small, chronically-ill patient populations. We 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 authorities. Furthermore, Grifols adheres to voluntary standards that go over and above current regulatory requirements. The 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 bodies. Adherence 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 medicines. Grifols is required by FDA to follow regulations governing plasma donor screening and qualifications. The FDA Code of Federal Regulations Title 21. Sec. 640.63 outlines donor suitability that all individuals are required to meet prior to donation. Grifols remains steadfast in our commitment to the highest standards of plasma quality and safety of our donors and employees. If 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, Inc. Center Manager, Richmond VA [redacted]

Review: I have been donating at this plasma center for about 6 months.No health issues I go regularly to my doctors every three months.Somehow all of a sudden they told me that I took a lab sample and my results came back that I could not donate.Not one time I could not donate but it has been three different times since I took my first lab sample.As of today July 8,2015 this is my third lab sample and they told me to wait 7 to 14 days for my results to come back.I would just like to make sure that this business is using proper protocol and are not altering lab results.This just seems out of the ordinary for this business for all of a sudden for me not to donate without really not telling me the real issue.I would like this situation looked into so it will not be anymore problems when I try to come back to donate there.Desired Settlement: Just to make sure that there are no other issues with organizations,or people illegally altering or trying to stop me from donating here at this business.It just seems not normal at this particular business.I never had any issues until now.

Business

Response:

Thank you for the opportunity to respond to case #[redacted], we take these concerns seriously. Grifols is a major manufacturer of life-saving plasma therapies produced from donations of human plasma that are used to treat small, chronically-ill patient populations. We 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 authorities. Furthermore, Grifols adheres to voluntary standards that go over and above current regulatory requirements. The 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 bodies. Adherence 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 medicines. Grifols is required by FDA to follow regulations governing plasma donor screening and qualifications. The FDA Code of Federal Regulations Title 21. Sec. 640.63 outlines donor suitability that all individuals are required to meet prior to donation. Grifols remains steadfast in our commitment to the highest standards of plasma quality and safety of our donors and employees. If 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, Inc. Center Manager, Richmond VA [redacted]

Consumer

Response:

I have reviewed the offer and/or response made by the business in reference to complaint ID [redacted], and have determined that this proposed action would not resolve my complaint. For your reference, details of the offer I reviewed appear below.

[Provide details of why you are not satisfied with this resolution.]

Regards,

Hello,I reviewed the email sent to me,I do not have a problem with the screening process,my issue is with the unexplainations that I were not given.All I was told was that I could not donate,no one explained to me why.I would just have to keep coming back until I guess I was able to donate.That was not proper protocol,I was suppose to get a detailed explanation of why my results came back the way that they did.I really do believe that this is a further issue that needs to be looked into.Maybe the nurse should had explained to me but they did not,they just kept asking me if I wanted to take another sample.Well,maybe when I go back for my next lab test sample results they will know what they need to do as far as telling the donor all of the details and things that they need to know if it has to do with there health.