FDA Sends Warning to Boston Scientific

Boston Scientific fresh off its acquisition of Guidant Corporation, has been sent a warning letter by the FDA. Federal regulators said they discovered problems in the medical device maker’s quality control. FDA officials who announced the warning involving Boston Scientific said it was only the third time in the agency’s history it has issued such a broad companywide warning involving a medical device company’s systems to identify potentially defective and unsafe products.
“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.
Natick-based Boston Scientific said it was cooperating with the FDA and hoped to fix the problems promptly.
Guidant spokesman Steve Tragash said his company had been aware of the issues from its due diligence talks with Boston Scientific in recent weeks.
“We do not expect this development to interfere with the progress of the pending merger between Guidant and Boston Scientific,” Tragash said.
The FDA found violations in responding to doctors’ reports about possible product defects and Boston Scientific’s reporting of quality control issues at three Boston Scientific plants the agency inspected late last summer. The FDA also said the company’s efforts to fix problems at three other sites cited in previous FDA warnings were inadequate.