Reuters reports today that Guidant Corporation has received a warning letter from the U.S. Food and Drug Administration related to the agency’s prior inspection of the company’s heart rhythm management device facility in St. Paul, Minnesota.
The FDA’s inspection was finished on September 1, 2005, and resulted in requests for quality control improvements. Guidant said it has provided the FDA with monthly updates on its progress and has so far completed 90 percent of its commitments.