FDA to Inspect Boston Scientific's Galway Plant

Published: September 1, 2004
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FDA to Inspect Boston Scientific's Galway Plant



Originally Published MX September/October 2004

BUSINESS NEWS

In a continuing effort to determine the extent of manufacturing problems related to the catheter delivery system for Taxus drug-eluting and Express bare-metal coronary stents by Boston Scientific (Natick, MA), FDA has announced plans to inspect the company's production facility in Galway, Ireland, in "the near future."

The agency's decision to inspect the Galway plant was first revealed by the Wall Street Journal and was picked up by numerous news services. There is no mention of the inspection on FDA's Web site, nor has the agency announced a date for its site visit. Similarly, Boston Scientific had no public comment on the matter.


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