St. Jude Medical has been warned by the FDA that its manufacturing practices at two of its facilities need to be improved. St. Jude said it is complying with the warning letter and expects eventually to resume receiving export certificates and pre-market approval applications for its Class III devices. Those two advantages are denied the company until it complies with good manufacturing practices at the plants. The FDA complaints involve St. Jude’s neuromodulation division at a plant in Texas and another in New Jersey. St. Jude said it expects no impact on customer orders. (Click here for more)
“St. Jude Medical Gets FDA Warning On Two Facilities” – Reuters (7/2/09)
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