FDA clears St. Jude's Calif. plant

Star Tribune (Minneapolis, MN) |

July 02--The government expressed satisfaction with improvements at a factory where St. Jude Medical Inc. makes defibrillator parts, the company said Wednesday, clearing an issue that threatened approval of new products.

The U.S. Food and Drug Administration in January last year sent a warning letter to the company about processes at St. Jude's plant in Sylmar, Calif., where it made leads for its primary defibrillator, called Durata. A lead is a wire that connects the defibrillator to a heart.

FDA inspectors in September 2012 raised several concerns, including over the number of times that tests were performed on the leads. The company a month later told investors it expected to receive the warning letter. It subsequently publicized steps it was taking to address the FDA's concerns, including bolstering training for workers.

When it issued the warning, the FDA raised no concerns about the Durata lead or other St. Jude products.



In announcing the FDA's clearance of the matter, St. Jude said little about the changes it has made at the Sylmar site over the last 18 months. The firm continued operating the factory throughout the FDA's intensive oversight of it.

"We are encouraged by the resolution of the FDA's warning letter and will continue to work to ensure the highest standards are met across all our manufacturing facilities," Dan Starks, chief executive of St. Jude, said in a statement.

FDA warnings can prevent a company from getting products approved by the regulator until deficiencies are corrected.

Early this year, however, it was clear that the matter was having little effect on St. Jude as the FDA approved several new heart-related products it developed, including a new defibrillator lead and a new line of pacemakers.

St. Jude shares were up 0.3 percent in midday trading following the news.

When the warning letter was initially issued, St. Jude told investors it was "giving the highest priority to fully remediating these concerns."

Evan Ramstad -- 612-673-4241

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