St. Jude Medical (NYSE:STJ) said today that the FDA cleared it of manufacturing violations at a Plano, Texas, plant the watchdog agency flagged in a 2009 warning letter. It’s the 2nd such letter to be cleared by the watchdog agency in as many months.
The Plano facility was acquired when St. Jude paid $1.3 billion for Advanced Neuromodulation Systems in 2005. In 2007, St. Jude initiated a field action after discovering software and hardware defects in some of its Eon spinal cord stimulation devices intended to treat chronic pain, according to the warning letter.
The FDA inspected the plant in March and April 2009, finding problems with St. Jude’s procedures for correcting and preventing problems with the Eon devices, according to the letter. In July 2012 St. Jude recalled some of the Eon and Eon Mini pain management implants due to battery failures and overheating during recharge.
"We’re pleased to have resolved the concerns identified by the FDA at our Plano manufacturing facility," chairman, president & CEO Daniel Starks said in prepared remarks. "We take quality and compliance seriously and are committed to meeting and exceeding patient, physician and regulator expectations in these areas."
Earlier this month, St. Jude closed the $200 million acquisition of NeuroTherm, adding that company’s radiofrequency ablation technology to its pain management portfolio. Last month St. Jude said the FDA cleared another warning letter, issued in 2013, over problems at a plant in Sylmar, Calif., that makes defibrillator leads.
