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St. Jude Warning Letter Updates: CRM Facility Reinspected; Neuro Plant Awaits FDA Visit

St. Jude updated the status of its efforts to resolve FDA warnings letters linked to its cardiac rhythm management and neuromodulation divisions during its first-quarter earnings call on April 16.

St. Jude Medical Inc. says FDA has completed a reinspection of its Sylmar, Calif., cardiac rhythm management device facility that drew an FDA warning letter in 2013 and it remains on track to have the letter closed out this year.

Meanwhile, the firm is waiting for FDA to inspect its remediation of its Plano, Texas neuromodulation facility, which was the subject of an FDA warning letter last summer.

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