Travenol Laboratories implemented a Guidance for Permanent Donor Records. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities. Read more about Travenol Laboratories implemented a Guidance for Permanent Donor Records. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities.
Travenol Laboratories implemented a Guidance for Donor Requirements Check List. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities. Read more about Travenol Laboratories implemented a Guidance for Donor Requirements Check List. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities.
A letter from Dr Moshe Sternberg to Dr Elaine Esber details an example of the Cutter System of Plasmapheresis documents. Read more about A letter from Dr Moshe Sternberg to Dr Elaine Esber details an example of the Cutter System of Plasmapheresis documents.
Dr John Petricciani wrote to Dr Steven Ojala evidencing that both Cutter's own centres and contracted centres were inspected by Cutter's internal plasma procurement department, as well as the FDA and state authorities. Read more about Dr John Petricciani wrote to Dr Steven Ojala evidencing that both Cutter's own centres and contracted centres were inspected by Cutter's internal plasma procurement department, as well as the FDA and state authorities.
A 25-page FDA instruction booklet was published setting out in detail the matters to be inspected prior to product licensing, including the requirements for donor identification and consent, the medical examination of donors, the process of obtaining plasma, record keeping, plasma separation and pooling following donations, the equipment used for plasmapheresis, testing for Hepatitis B surface antigen, (and) product labelling,. Read more about A 25-page FDA instruction booklet was published setting out in detail the matters to be inspected prior to product licensing, including the requirements for donor identification and consent, the medical examination of donors, the process of obtaining plasma, record keeping, plasma separation and pooling following donations, the equipment used for plasmapheresis, testing for Hepatitis B surface antigen, (and) product labelling,.
Dr Thomas referred to pools of 6,000 donors in his 1972 report on Hyland facilities, which was considered as part of the Hemofil product licence application. Read more about Dr Thomas referred to pools of 6,000 donors in his 1972 report on Hyland facilities, which was considered as part of the Hemofil product licence application.
Three prison centres were included in a list of plasma sources in a document that was compiled as part of a UK product licence application for Koate. These were Arizona State Prison, the Southern Desert Correctional Center and the Northern Nevada Correction Center. Read more about Three prison centres were included in a list of plasma sources in a document that was compiled as part of a UK product licence application for Koate. These were Arizona State Prison, the Southern Desert Correctional Center and the Northern Nevada Correction Center.
Ed Harriman wrote an article in New Scientist noting that "Not surprisingly, Dr Z F Hantchef, head of the Red Cross's Blood Transfusion Service in Geneva, hotly denies Ramos's claim. For years, he has been speaking out against unscrupulous dealers." Read more about Ed Harriman wrote an article in New Scientist noting that "Not surprisingly, Dr Z F Hantchef, head of the Red Cross's Blood Transfusion Service in Geneva, hotly denies Ramos's claim. For years, he has been speaking out against unscrupulous dealers."
Edward Harriman witnessed how brisk business was being done obtaining cheap plasma from the riskiest of sources, for onward sale, though he did not see for himself any evidence of to whom that sale was being made. Read more about Edward Harriman witnessed how brisk business was being done obtaining cheap plasma from the riskiest of sources, for onward sale, though he did not see for himself any evidence of to whom that sale was being made.
Hyland targeted gay men for whole blood donations for the purpose of obtaining hyperimmunised plasma, and while Hyland did not use plasma recovered following this process for its own factor concentrates it did sell this on to Alpha, and Alpha then used that plasma as part of its pools when manufacturing factor concentrates. Read more about Hyland targeted gay men for whole blood donations for the purpose of obtaining hyperimmunised plasma, and while Hyland did not use plasma recovered following this process for its own factor concentrates it did sell this on to Alpha, and Alpha then used that plasma as part of its pools when manufacturing factor concentrates.