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

___

(c)2014 the Star Tribune (Minneapolis)

Visit the Star Tribune (Minneapolis) at www.startribune.com

Distributed by MCT Information Services

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Companies

Symbol Name Price Change % Volume
SPIR Spire Corp 0.01 0.00 0.00 0

Comments

Emerging Growth

Liberty One Lithium Corp

Liberty One Lithium Corp is a mineral exploration company engaged in acquisition and development of high grade lithium brine deposits.

Private Markets

Quants Inc

Quants, Inc, a California Corporation, develops, markets and operates financial technology platforms and alternative investment products offering sophisticated risk management since 2010. The Company has primarily sharpened its focus with…

CF0005, LLC dba Mesa-Marshall #1-2

MESA Resources, Inc. ("MESA") is sponsoring the development of the oil & gas well completion project "Mesa-Marshall #1-2". MESA, founded in 1992, is engaged in the acquisition, exploration and development…