Boston resolves long-standing FDA warning
This article was originally published in Clinica
Executive Summary
Boston Scientific has been notified by the US FDA that all issues concerning a warning letter issued in 2006 have been resolved. The Natick, Massachusetts-based firm was originally warned about problems with procedures, processes and timelines in its quality system at three of its US manufacturing facilities (www.clinica.co.uk, 3 February 2006). In its 2009 annual report filed with the US Securities and Exchange Commission, Boston said that it had identified solutions to the quality system issues cited by the FDA and have made significant progress to implement these solutions. The firm also said that since it received the warning letter, its manufacturing plants had been reinspected several times and had met FDA approval.
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