FDA Warns Heart Device Maker About Calif. Plant

FDA has sent a warning letter to medical device maker St. Jude Medical citing manufacturing and quality-control issues at a facility located in Sylmar, Calif. Under the terms of the warning letter, FDA will not approve any new heart-rhythm products manufactured at the plant until the problems are fixed.

• "FDA Sends Warning Letter to a Maker of Defibrillators" (AP/New York Times, 1/14).
• "FDA Sends St. Jude Warning Letter Over Calif. Plant" (AP/Modern Healthcare, 1/14).
• "St. Jude Receives FDA Warning Letter on Heart Devices" (Weaver, Wall Street Journal, 1/14).