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China plant implicated in heparin scare "never" inspected by FDA

www.outsourcing-pharma.com

Questions are hanging over the role of a Chinese manufacturing facility in the Baxter heparin scare after it has emerged that the US Food and Drug Administration (FDA) has never inspected the facility.
Baxter has this week suspended the production of its blood-thinning drug heparin in multi-dose vials, following the deaths of four patients in the US who were given the drug in high doses, along with 350 reports of severe allergic reactions to the drug, with symptoms including a rapid drop in blood pressure, burning sensations, headaches, throat swelling and a shortness of breath.

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