stj042209
On the homepage
Crimefighting
Out There
Mental health
Health care
FDA warns St. Jude about quality at Minnetonka plant
Print this story
E-mail this story
Save to del.icio.us
Share on Facebook
Share on Digg
Minnesota business by the numbers
See Minnesota's top earning companies, CEOs and non-profits
More from Business
St. Jude Medical Inc. said Tuesday it received a letter from the Food and Drug Administration (FDA) regarding poor quality practices at a manufacturing plant in Minnetonka.
A warning letter from the federal agency could hamper the company's ability to introduce some new products in its fast-growing $546 million atrial fibrillation division.
In an April 17 letter, the FDA cited manufacturing and assembly functions related to the Safire ablation catheter, according to a securities filing by Little Canada-based St. Jude. In 2008, the company sold $6 million of the catheters.
The FDA said it will not grant requests to export products named in the letter or approve Class III devices related to the plant's products. In general, this classification covers more sophisticated -- and profitable -- devices.
St. Jude said it proposed corrective actions and said the matter could be resolved without affecting financial results. The company reports first-quarter results today.
Janet Moore • 612-673-7752
Recent Business stories
West Virginia regulators approve 5 percent rate increase for Hope Gas - April 22, 2009
West Virginia regulators approve 5 percent rate increase for Hope Gas - West Virginia's Public Service Commission has approved a 5 percent rate increase for Hope Gas Inc. More
Blog: Patent Pending
Lights out at U energy conference. Irony police notified.
Just as Lawrence Kazmerski, a top official at the National Renewable Energy Laboratory, was about to give the keynote address at the University of Minnesota's annual E3 conference at the RiverCentre in St. Paul, the lights went out, bathing the audience in darkness and a deep sense of irony.
Comment on this story | Be the first to comment | Hide reader comments