A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
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