FDA says clerical mix-up led to heparin plant inspection failure

The US Food and Drug Administration says that a documentation error was responsible for its failure to inspect a Chinese production facility involved in the manufacture of Baxter Healthcare's blood-thinner heparin (see page 13). John Famulare, deputy director of the agency's center for drug evaluation and research, said that regulators reviewing Baxter's application had mistakenly referred to inspection records for a like-named plant, rather than the Changzhou-based facility which supplies the US firm with ingredients.

Mr Famulare declined to name the Chinese firm that had been approved by mistake and asserted that, to date, the FDA believed the mix-up was an isolated situation. Previously, however, one of the criticisms levelled by members of the US Congress related to the "disastrous state" of the FDA's foreign inspection program (Marketletter February 18). At the time, Representative John Dingell (Democrat Michigan) said that the agency even seemed uncertain of the number of ex-US drugmakers on its books, with one database saying there are 7,000 while another lists just 3,000.

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