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The US Authorities inspected the facilities related to the production of heparin in the plants of Palafolls and Probisa.
They focused on ensuring that our traceability system meets the standards currently required by the FDA, which apply to the documentary as well as to the production levels (from the slaughterhouses, to the control of our satellite plants until the final API).
Last May Bioiberica had a non scheduled inspection from the US FDA in its facility in Geneva (Nebraska) where the first steps of heparin sodium production are performed.
in order to promote the development of new markets of sodium heparin, lithium heparin and heparin derivates.
Its worth mentioning a collaborative study organized by the NIBSC / USP with the aim to establish the molecular weight standard range for the revision of the USP sodium heparin monograph, official in the U.S. and foreseen to come into force in May 2014.
The US Authorities inspected the facilities related to the production of heparin in the plants of Palafolls and Probisa.