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." Read more about 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."
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. Read more about 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.
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. Read more about 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.
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." Read more about 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."
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." Read more about 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."
Armour had undertaken that plasma "will be only from donor centres in the USA, and from USA sources." Read more about Armour had undertaken that plasma "will be only from donor centres in the USA, and from USA sources."
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. Read more about 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.
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. Read more about 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.
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). Read more about 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).
The Abbott/Alpha product, Profilate, was licensed in 1975 initially with the following warning: "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present". Read more about The Abbott/Alpha product, Profilate, was licensed in 1975 initially with the following warning: "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present".