St. Jude Medical Clears FDA Issues over California Plant

By Nancy Crotti

A California plant operated by Little Canada, MN-based St. Jude Medical recently won a reprieve from the FDA over violations cited following a plant inspection in 2012. The facility manufactures the company's next-gen Durata defibrillator leads.

In its Form 483 warning letter, the FDA had cited 11 quality control and documentation issues at the Sylmar, CA, plant. According to information from an SEC regulatory filing, the company decided to ignore the warning letter.

However, the FDA notified St. Jude in a June 30 letter that the company had addressed the issues cited in the warning letter. It warned, however, that it would continue to monitor compliance at the plant.

The company had expected the warning letter and said so during its October third-quarter conference call.

The recent Riata lead recall, FDA warnings and issues at the Sylmar plant have led to a challenging business environment for the company. However, it continued to manufacture and ship products from the Sylmar plant during the warning period.

"We take our responsibility as a medical device manufacturer very seriously," Dan Starks, chairman, president and CEO at St. Jude Medical, said in a statement. "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 our manufacturing facilities."

The recent news about the Sylmar plant comes on top of St. Jude Medical's Wednesday announcement of second-quarter sales and earnings that were up year-over-year. St. Jude earned $270 million off $1.45 billion in sales during the quarter ended June 28, an increase from $115 million in profits and $1.40 billion in sales during the similar quarter in 2013.

Nancy Crotti is a contributor to Qmed and MPMN.

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