Boston Scientific Corp. was issued clearance for all of the issues raised in a warning letter sent to the company by the U.S. Food and Drug Administration nearly four years ago.

In January 2006 the watchdog agency issued a letter to Chairman Peter Nicholas and then-CEO James Tobin, stating that FDA inspections of six of the company’s facilities “revealed serious regulatory problems involving your medical devices.”

The facilities under scrutiny were in Natick, Watertown and Quincy, Mass., Maple Grove, Minn., Spencer, Ind., and Glens Falls, N.Y. The January letter came after three warning letters were issued regarding the Watertown, Glens Falls and Quincy facilities and after the company told the FDA it was moving quickly to “correct noted deficiencies.”
“Each of these warning letters,” the FDA wrote, “identified serious, systemic problems with your overall corporate quality management systems.”

The January letter called on the company to meet with the FDA.

Ray Elliot, the company’s current president and CEO, called the resolution “a major milestone in our journey of continuous quality improvement,” in prepared remarks.

In order for the issues to be resolved, the company had to work to fix the problems raised in the corporate warning letter, explained Tim Ulatowski, director of the FDA’s Center for Devices and Radiological Health (CDRH).

“We re-inspected all of the sites involved in the letter,” he told DOTmed News. “As far as the…violations observed related to the corporate warning letter in 2006, [the company] addressed those.”

Ulatowski said the agency will continue monitoring the company’s compliance to regulations.

Boston Scientific recently predicted a $300 million loss in sales as a result of its month-long recall in March of ICDs.

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