The Food and Drug Administration said an inspection of
Watertown, Mass., facility found problems involving the manufacturing of the company's Vaxcel device.
From March 9 through April 7, the FDA inspected the facility and found "serious regulatory problems" involving implantable Vaxcel Low Profile Infusion Ports. According to the letter, the inspection revealed that the methods or facilities used for making, packing, storing or installing the products don't conform with the current good manufacturing practice requirements for medical devices.
Problems included failure to establish adequate management controls to ensure that an effective quality system has been established and maintained, the letter indicated.
The FDA said Boston Scientific must promptly initiate "permanent corrective and preventive action." The agency said the company needs to move on the matter now and let it know what steps have been taken to correct the problems within 15 business days, along with a plan to prevent the issue from arising again.
Shares of Boston Scientific were down 40 cents to $27.55, a 52-week low.