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Heart Device Maker Warned by FDA

Frank Hoffman12 months ago

The U.S. Food and Drug Administration issued a warning letter to St. Jude Medical following an inspection of one of the company’s manufacturing plants.

Details of the Warning

Reuters reports that Heart Device Manufacturer St Jude Medical received a warning from the FDA due to concerns regarding the quality standards of several devices manufactured at their Atlanta, Georgia plant.

During a period in June, the FDA conducted inspections in St Jude’s Atlanta facility, where the company primarily manufactures the heart failure monitor CardioMEMS HF system.

In a September 30th letter the FDA expressed issues with the company’s manufacturing process stating that St Jude Medical’s practices are “not in conformity” with current guidelines which the regulator has in place.

St. Jude Previously Warned by FDA

St. Jude expressed that it had no plans to cease device production at their Atlanta facility and that they did not anticipate any interruption in customer orders as a result of the warning.

The FDA has previously warned the company about its manufacturing procedures in the past. In 2013 the regulator cited violations at the manufacturer’s Sylmar, California plant; these issues included serious issues with the company’s testing procedures.

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