The Food and Drug Administration issued a warning letter to medical-devices maker
for distributing faulty stents, sending the company's shares lower Tuesday.
Boston shares lost $1.15, or 4.2%, to $26 in recent trading.
The FDA letter, dated Aug. 10 and made public Tuesday, said an inspection of Boston Scientific's Quincy, Mass., facilities showed "serious regulatory problems involving your medical devices, including the implantable Vaxcel Low Profile Infusion Ports, Taxus paclitaxel drug eluting stents, and Symmetry balloon dilatation catheters."
Among other things, Boston Scientific's methods or controls used to manufacture and store the products didn't meet the "good manufacturing practice" requirements for medical devices, the letter indicated.
The FDA also wrote that "on a number of occasions, your firm shipped medical devices that were not considered acceptable for release," including certain Taxus Express 2, Monorail and paclitaxel-eluting coronary stent systems. The faulty stents were sent to five hospitals on Jan. 20 and Jan. 21, 2005.
"Through a failure of your quality system," two Boston Scientific employees released the devices, according to the FDA.
"It's important to note that this is a shipping problem, not a manufacturing problem," says Boston Scientific spokesman Charles Rudnick.
The FDA also says Boston Scientific misbranded its Vaxcel low-profile infusion valved ports and improperly released some of its Symmetry balloon dilatation catheters as finished goods.
"We are actively working on every point raised by the FDA in its letter, and have already completed corrective actions in a number of areas," Rudnick says. The FDA examined thousands of shipping records, and the errors the agency found had already been identified by the company.
Boston Scientific responded to the agency's concerns in June, but the FDA says the company didn't provide enough details about its corrective actions.