News | August 19, 2010

FDA Absolves Boston Scientific of Safety Issues

August 19, 2010 – The U.S. Food and Drug Administration (FDA) said last week Boston Scientific has resolved all the manufacturing safety issues cited in a 2006 corporate warning letter.

Nearly four years ago, the FDA warned the company that multiple inspections of manufacturing facilities revealed serious regulatory problems involving its medical devices. The letter warned Boston it had taken inadequate corporate-wide corrective action, which the FDA said continued to cause serious deficiencies at each of its facilities. The problems involved several Boston Scientific products, including the Taxus drug-eluting stent and the Leveen needle electrodes. Plants cited were in Natick, Watertown and Quincy, Mass.; Maple Grove, Minn.; Spencer, Ind.; and Glens Falls, N.Y.

“The resolution of the corporate warning letter marks a major milestone in our journey of continuous quality improvement,” said Ray Elliott, Boston Scientific’s president and CEO. “Quality is our highest priority and our greatest responsibility. While our quality work will never be done, we have revolutionized our approach and transformed our culture, and we are confident that our commitment to the highest levels of quality will create a competitive advantage for Boston Scientific.”

Over the past year, the company has undergone numerous changes, including changes in management.

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