FDAnews
www.fdanews.com/articles/152456-st-jude-takes-steps-to-address-issues-at-california-durata-plant

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

January 17, 2013
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.
Devices & Diagnostics Letter