St. Jude Medical received a five-observation warning letter regarding problems found during a 2012 inspection of its Sylmar, Calif., heart lead facility. Problems included inadequate device verification procedures, failure to properly monitor validated processes, failure to validate device design, lack of adequate design history files and inadequate corrective and preventive action procedures. St. Jude also did not report Durata-related MDRs within 30 days, according to the letter.
St. Jude’s response to the Form 483 was not detailed enough to resolve the FDA’s concerns and the warning letter had been widely anticipated. Two weeks ago, the FDA made the company’s Form 483 response publicly available.
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