FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial

horizonal rule

FDA Statement

FOR IMMEDIATE RELEASE
Statement
February 3, 2006

Media Inquiries:
 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Statement Regarding Boston Scientific Corporation

Boston Scientific Corporation met today with the U.S. Food and Drug Administration to discuss the company's plans for responding to the Corporate Warning Letter they received on January 26, 2006. The Company acknowledged the FDA's assessment of corporate-wide quality system and device reporting deficiencies and confirmed the firm's commitment to resolving all issues according to an aggressive timeline.

The FDA expressed its commitment to responding to any and all questions, plans and scheduling of verification inspections in an equally timely manner.

####

RSS Feed for FDA News Releases [what's this?]

rule Get free weekly updates about FDA press releases, recalls, speeches, testimony and more. rule