FDA says manufacturing issues at St. Jude plant resolved

July 2, 2014 2:30 PM

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(Reuters) - St. Jude Medical Inc said the U.S. Food and Drug Administration notified the company that issues regarding its Sylmar, California-based manufacturing plant have been resolved.

The FDA last year had warned St. Jude of serious violations at the plant where the Durata and Riata leads for implantable defibrillators are made. Violations included a failure to validate testing methods. [ID:nL2N0D40KS]

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