Boston Scientific Stung With Across-The-Board Corporate Warning Letter
This article was originally published in The Gray Sheet
Executive Summary
FDA is targeting Boston Scientific with a rare and far-reaching enforcement measure that could prevent some of the firm's investigational products from receiving market approval in the near term
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Boston Scientific says Aug. 11 it has resolved all outstanding issues cited in a Jan. 25, 2006, corporate-wide 1warning letter that identified "serious, systemic problems" with the firm's quality system and adverse event reporting programs (2"The Gray Sheet" Jan. 30, 2006). The letter barred Boston Scientific from marketing Class III devices until the violations were corrected, but the firm made enough progress to convince FDA to lift the marketing restrictions in October 2008. Nevertheless, full resolution marks a "major milestone," CEO Ray Elliott said in an Aug. 11 statement. "We have revolutionized our approach and transformed our culture.
Boston Scientific warning letter lifted
Boston Scientific says Aug. 11 it has resolved all outstanding issues cited in a Jan. 25, 2006, corporate-wide 1warning letter that identified "serious, systemic problems" with the firm's quality system and adverse event reporting programs (2"The Gray Sheet" Jan. 30, 2006). The letter barred Boston Scientific from marketing Class III devices until the violations were corrected, but the firm made enough progress to convince FDA to lift the marketing restrictions in October 2008. Nevertheless, full resolution marks a "major milestone," CEO Ray Elliott said in an Aug. 11 statement. "We have revolutionized our approach and transformed our culture.