St. Jude Gets Expected Form 483, Warning Letter Still a Possibility
St. Jude filed an Oct. 24 Form 8-K with the SEC stating the company had received a Form 483 for observations made during a Sept. 25 to Oct. 17 FDA inspection of its Sylmar, Calif., cardiac rhythm management plant. The 11 observations concern the plant’s process and design validation, design change procedures, corrective and preventive action systems and document control. The GMP Letter
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!
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