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Abbott/Alpha stated that tests had been negative for the presence of hepatitis, but not "all units" of "potentially" infectious plasma could be detected so the risk (the inference is, only a little) was "still present" (their later data sheets did however advise the use of single-donor products where possible).

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The licencing authority invited the Minister to make it a requirement of the licence that plasma should be obtained only from donor centres in the US or other specified countries that satisfied the licensing authorities.

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The requirement that plasma should be obtained only from donor centres in the US or other specified countries that satisfied the licensing authorities was followed in the product licence.

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Armour had undertaken that plasma "will be only from donor centres in the USA, and from USA sources."

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Armour stated in correspondence to the DHSS that "the number of donations is approximately 1,540 per batch to give a pooled plasma of approximately 1,000 litres."

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Robert Christie stated that he understood "that Armour US purchased small amounts of plasma necessary to address shortages. I do not know the details of any such purchases."

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Armour did not use prison plasma in 1982 and showed no interest in suggestions made in April 1985 that the use of screening tests and heat treatment might permit a return to the use of prison plasma in factor concentrates.

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When Armour applied for a product licence for a high potency variant of Factorate, the company stated that all plasma was collected from establishments licensed by the FDA "and transferred to Armour under conditions defined" in the Code of Federal Regulations.

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Armour, in common with Immuno and Alpha, began by emphasising the precautions taken to render the product safe before saying that despite these the product "may contain causative agents of viral hepatitis."

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In his report of his visit to plasmapheresis centres, Dr Peter Jones commented that: "It is imperative that the Revlon Health Care Group [which owned Armour] became totally self-sufficient in terms of source plasma."

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Armour published Plasma Perspectives No 1 which referred to Factorate being manufactured from pools of "only approximately 2,000 donors." It is not clear if this is a less precise formulation of the same idea, or whether it reflects an increase in the size of the plasma pools between the mid 1970s and 1981.

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Armour stated that: "Plasma Alliance's [the plasma collection company affiliated with Armour] 22 centres are responsible for collecting from approximately 22,000 donors registered at any one time." Annually, over one million plasma donations were processed. It follows that a patient receiving a single infusion of Factorate in the later 1970s would be exposed to somewhere in the region of 1,540 donations.

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Dr Michael Rodell sent a telex to W Tarbit which showed that self-sufficiency, at least for Factorate, had been achieved by June 1983.

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W Tarbit sent a telex to Dr Rodell suggesting that Armour might still, on occasion, be reliant on external purchases. It seems that this may have been a provisional view expressed by the officers of the UK subsidiary before the definitive answer was received from Dr Rodell of the US parent company.

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H L Shaw sent a telex to Kas Egerton contributing to the provisional view that Armour might still, on occasion, be reliant on external purchases, before the definitive answer was received from Dr Rodell of the US parent company:

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Dr Thomas Cleghorn stated in an interview that he had been told that from November 1975 only plasma from the mainland US would be used.

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Dr Jones drafted a memo describing the circumstances in which he was invited by Armour to inspect and report on facilities supplying Armour with plasma through its subsidiary company, Plasma Alliance.

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Immuno employed a system of "Neutral texts" (wording that could be used in any countries where there was no requirement for a specific formulation, including for unlicensed products in the UK) and "UK specific texts" which had the approval of the UK licensing authority and had to be used for a licensed product.

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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.

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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.

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