Guidant Gets FDA Warning Letter on FacilityDec 27, 2005 | AP
Guidant Corp., one of the nation's top makers of pacemakers and heart defibrillators, said Tuesday that it received a warning letter from federal regulators regarding its operations in St. Paul, Minn.
Guidant said the warning, which comes from the Food and Drug Administration, is for the company's manufacturing, research and sales center in St. Paul. The FDA finished an inspection of the center, known as the company's Cardiac Rhythm Management facility, in September.
Guidant received the FDA's warning letter last Friday. The letter indicates that the FDA won't grant any of the company's requests for exportation certificates to foreign governments, or approve the company's applications for certain medical devices until Guidant takes steps to resolve the agency's concerns.
Guidant said it has thoroughly reviewed its St. Paul system and has made substantial steps toward addressing all the FDA's observations that prompted the warning letter. The company also said it believes it can fully address the FDA's concerns without seriously affecting its business.
The company disclosed in September that the FDA had raised some concerns about its St. Paul operations. The company said at the time that it planned to improve its product labeling and provide more frequent and detailed product performance reports, but Guidant hadn't yet received a response from the FDA.