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C Chard wrote a memo to G Hardy providing evidence that plasma from outside the US and Europe was still being "routinely" used in the production of albumin products at its facility in Lessines, Belgium, that those products were imported to the UK, and that this was in contravention of the product licence that specified the use of US plasma.
Published on:
27 August, 2024
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.
Published on:
27 August, 2024
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.
Published on:
27 August, 2024
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."
Published on:
27 August, 2024
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.
Published on:
27 August, 2024
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.
Published on:
27 August, 2024
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,.
Published on:
18 October, 2024
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.
Published on:
27 August, 2024
A letter from Dr Moshe Sternberg to Dr Elaine Esber details an example of the Cutter System of Plasmapheresis documents.
Published on:
27 August, 2024
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.
Published on:
27 August, 2024
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.
Published on:
27 August, 2024
Travenol Laboratories implemented a Guidance for Source Plasma (Human) Label. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities.
Published on:
27 August, 2024
Travenol Laboratories implemented a Guidance for Whole Blood and Plasma Processing Log. This was described as akin to the quality assurance plans as part of product licence applications provided to UK authorities.
Published on:
27 August, 2024
A memo from Stewart Mueller to W Biles detailed Dr Jones's inspections of Plasma Alliance.
Published on:
27 August, 2024
A memo from Robert Spiller to Dr Harry Meyer criticised the Bureau of Biologics practice of giving advance notice before some inspections.
Published on:
27 August, 2024
William Hartin stated that dealing with paid donors increases the likelihood of people from the lower socioeconomic bracket becoming donors.
Published on:
27 August, 2024
Hyland and Cutter obtained plasma from plasmapheresis centres located in prisons in the US and used that plasma in the production of factor concentrates.
Published on:
27 August, 2024
Dr Ojala estimated that prison plasma accounted for approximately 2% of the total plasma collected in the US as of mid 1982 and was obtained from no more than six to eight centres.
Published on:
27 August, 2024
Hyland's policy as of the end of October 1983 was to discontinue the use of prison plasma for the manufacture of coagulation factors. However, "Any intermediate fractions manufactured from plasma pooled [that] week, or in previous weeks, would be processed to final product."
Published on:
27 August, 2024
Memo from Robert Barden to Dr John Hink recommended accepting an invitation from the warden of Arizona State Prison to establish a plasmapheresis centre there as it represented a "great opportunity for us to produce some low cost plasma."
Published on:
27 August, 2024
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