FDA warns heparin supplier over manufacturing
WASHINGTON (Reuters) - U.S. Food and Drug Administration officials warned Baxter International Inc's supplier of the blood thinner heparin for failing to ensure that its manufacturing process can remove impurities, according to a letter released on Monday.
"Equipment used to manufacture heparin sodium USP is unsuitable for its intended use," the FDA also said in a letter to the supplier, Changzhou SPL Company Ltd.
FDA inspectors, who visited the facility February 20-26, also found SPL did not properly evaluate its own suppliers, who supplied crude ingredients. The FDA failed to inspect the company before approving Baxter's heparin because of a mix-up with SPL's name.
Officials are investigating heparin after as many 62 deaths and hundreds of reactions were reported in patients given the injectable drug.
(Reporting by Susan Heavey; Editing by Derek Caney)
