St. Jude Resolves Warning Letter at Texas Facility

St. Jude Medical Inc. received U.S. Food and Drug Administration (FDA) notification that issues cited in the company’s Plano, Texas, facility’s warning letter have been addressed.

“We’re pleased to have resolved the concerns identified by the FDA at our Plano manufacturing facility,” said Daniel J. Starks, chairman, president and CEO of St. Jude Medical. “We take quality and compliance seriously and are committed to meeting and exceeding patient, physician and regulator expectations in these areas.”

The warning letter dates back to June  2009, following inspections by the FDA at the facility between March 5 and April 6, 2009. The FDA identified non-conformities with current good manufacturing practice.

St. Jude Medical acquired the Plano facility in 2005 as part of its $1.3 billion acquisition of Advanced Neuromodulation Systems.

Recently, St. Jude Medical purchased privately held chronic pain solutions maker NeuroTherm for cash payment of roughly $200 million. The acquisition boosted St. Jude Medical’s chronic pain portfolio and made it the only medical device producer with a chronic pain portfolio that offers both radio frequency ablation for spinal pain and spinal cord stimulation.