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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.
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