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
