Bioiberica SA passes satisfactorily US FDA Inspection of our new heparin facility Biolab SRL in Italy
Heparin Science Business Unit is glad to inform that our crude heparin facility in Italy passed satisfactorily a United States Food and Drug Administration (US FDA) Inspection for compliance with US FDA requirements.
The inspection of Biolab SRL took place last April 2012 and it was conducted by an Investigator from FDA CDER Office of Manufacturing and Product Quality to determine whether Biolab SRL is operating in accordance with the U.S. Food, Drug and Cosmetic Act, and regulations set forth in Title 21 of the U.S. Code of Federal Regulations that are applicable to our Heparin Sodium API.
This satisfactory inspection confirms our commitment to work according to the US FDA rules as it was evidenced with the former positive inspection by the US FDA of our plants producing Heparin Sodium: Bioiberica Palafolls located in Palafolls (Spain) and Productos Biológicos SA located in Olérdola (Spain).
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- One out of every 5 doses of heparin administered in the world comes from Bioiberica.