FDA tasks Boston Scientific over quality
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Manufacturing News, Source : The Manufacturer US
Published : 27 Jan 2006 14:32
What a difference a day makes in manufacturing. Just one day after Boston Scientific agreed to a $27 billion deal to buy Guidant Corp., the Food and Drug Administration (FDA) warned Boston Scientific in a letter that its quality practices are not up to snuff.
"The problems identified in this (warning) letter we consider to…involve the entire corporate structure," Dr. Daniel Schultz, head of the FDA's Center for Devices and Radiological Health, told reporters. The problems boil down to Boston Scientific’s non-performance in tracking product complaints. FDA believes BS management has failed to create systems to ensure the quality of its artery opening stents, catheters and needle electrodes.
Both Boston Scientific and Guidant have had product recalls, Boston Scientific’s being a voluntary recall of its Taxus drug coated stent in 2004, and Guidant recalling some heart defibrillators in 2005.
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