St. Jude Medical Receives Warning Letter for Texas, N.J. Facilities

St. Jude Medical Inc. has received a warning letter from the U.S. Food and Drug Administration for non-conformities with Good Manufacturing Practice at Texas and New Jersey facilities, according to the company in a regulatory filing.

The letter, dated June 26, said the FDA would not clear pre-market approval applications for the company’s Class III devices until the violations are corrected, according to St. Paul, Minn.-based St. Jude Medical.

Firm officials said it initiated efforts to address the FDA’s concerns, and the Neuromodulation division provided written responses to the FDA detailing proposed corrective actions at its Plano, Texas and Hackettstown, N.J., facilities.