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January 27, 2006 Categories: New articles Posted by admin
Federal regulators said Thursday that inspections at Boston Scientific Corp. plants found companywide problems in the medical device maker’s quality control, a finding that could block new product approvals as the company tries to conclude its biggest acquisition ever.
“We are directing them to resolve these serious violations promptly, and to do it not as it relates to specific products … but rather to do it on a corporate-wide basis,” said Daniel G. Schultz, director of the Food and Drug Administration office that regulates medical devices.
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