St. Jude Medical Inc. has received a warning letter from the FDA regarding its manufacturing practices at its Minnesota plant. The plant makes medical devices designed to correct atrial fibrillation disorders.
In its letter, the FDA made mention of St. Jude Medical’s Safire ablation catheter which is designed to disengage electrical signals that cause atrial fibrillation. The warning letter was issued as a result of a December FDA inspection of the Minnesota facility. Such a warning letter can result in the termination of production of the medical device in question if the company does not correct the problems cited in the warning letter.
Other medical device companies such as Stryker Corporation, Boston Scientific, and Johnson & Johnson have received similar warning letters in the recent past concerning other medical device products.