St. Jude Takes Steps to Address Issues at California Durata Plant

St. Jude Medical has launched sweeping revisions to internal procedures and documentation as part of its effort to resolve a Form 483 issued to its Sylmar, Calif., cardiac device facility last year.

The form stemmed from a Sept. 25 to Oct. 17 inspection that uncovered problems with the plant’s design history file, corrective and preventive action (CAPA) activities and complaint handling, as well as training issues. Following the inspection, St. Jude took the unusual step of announcing its belief that the deficiencies could result in a warning letter.

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