St. Jude Medical said it is taking steps to address concerns from the U.S. Food and Drug Administration about quality control issues related to the testing of medical device components.
The Little Canada-based company said it will work closely with the agency to resolve concerns about testing procedures and staff training at a California plant that develops wires that connect an implantable defibrillator to a patient's heart. The company said the FDA did not identify any specific issues with the performance of any St. Jude product.
Industry consultant David Furr said the company could keep the issue from escalating by satisfying the FDA.
"This is their opportunity to avoid a warning letter if this response is adequate and the FDA feel like they have taken appropriate measures to fix the violations that were noted during the suite inspection," Furr said.
If the FDA regards St. Jude's response as inadequate, the agency could limit the company's ability to export products and bring new devices to market.
"The ball is back in the FDA's court and the FDA will decide if their response is adequate and reasonable, if management understands the issues and has put appropriate methodology in place to correct those issues," Furr said.
The FDA could also subject St. Jude to increased scrutiny. If the FDA deems St. Jude's response is inadequate, the agency could limit the company's ability to export products and to bring new devices to market.