St. Jude Receives Expected Warning Letter
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.
Do you know what one marketing mistake hit 10 devicemakers with warning letters in 2011? You can learn this and more by ordering FDanews’ FDA Device Enforcement: An Analysis of Warning Letter Trends.
This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sites in the months ahead. Remember, there are more audits now more than ever. If you’re targeted, you’ll be facing better-trained inspectors. Now is the time to get 100 percent clear about compliance hot spots and key actions that can protect you from costly warning letters. Order your copy today.