St. Jude Medical Inc. yesterday confirmed in a press release that FDA concerns over products manufactured in Plano, TX, detailed in a nearly five-year-old warning letter, have been resolved.

The letter, dated June 26, 2009, regarded an FDA Form 483 List of lnspectional Observations from an earlier visit. At issue were neuromodulation device operation flaws that impacted products at St. Jude-owned Advanced Neuromodulation Systems Inc., later St. Jude Neuromodulation Systems Inc., following an FDA inspection of the plant on March 5 through April 6, 2009.

The plant produces spinal cord stimulation systems to treat chronic core and limb pain. Devices include a rechargeable or a primary cell implantable pulse generator (IPG), an external multiprogram trial stimulator (MTS), implantable leads, an external patient programmer, and an external charging system.

Officially, the devices did not conform with "Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820."

St. Jude had explained in a response to the inspection that it intended to remove defective MTS trial stimulators impaired with a known software defect. The neuromodulation manufacturer planned to ship replacement IPG chargers in the field and redesign the charging systems of the IPG to correct lack of stimulation, communication errors between the implant IPGs and their charging systems, and corrupt programs.

FDA's warning letter said St. Jude's corrective actions were good steps but "they did not address the gaps in [the] company's design and production controls that caused the quality problems in the first place." This week's good news on resolving the 2009 violations was welcomed.

"We're pleased to have resolved the concerns identified by the FDA at our Plano manufacturing facility," Daniel J. Starks, chairman, president and chief executive officer at St. Jude Medical said in the release. "We take quality and compliance seriously and are committed to meeting and exceeding patient, physician, and regulator expectations in these areas."

Recently, St. Jude Medical has addressed other regulatory troubles. A 2012 inspection of a plant in Sylmar, CA, resulted in an FDA Form 483 warning letter with 11 quality control and documentation issues. This June, FDA cleared the plant of the citations but warned that it would continue to monitor the plant.  

Anastasia Thrift is a contributor to Qmed and MPMN.

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