Interventional device developer Boston Scientific of Natick, MA, was warned by the Food and Drug Administration about regulatory problems with its medical devices, including the firm's Taxus coronary artery stent.
The warning, which also targeted Boston Scientific's Vaxel ports and Symmetry catheter, followed an inspection of Boston Scientific's Quincy, MA, shipping facility earlier this year. The FDA said the company responded in June to its concerns, but did not give enough detail about corrective actions.
The firm said it was working to address the FDA's concerns and had already taken some corrective actions. The company noted that none of the distribution problems had harmed any patients.
By AuntMinnie.com staff writers
August 24, 2005
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