FDAnews
www.fdanews.com/articles/130993-fda-gives-warning-to-cti-for-notification-problems

FDA Gives Warning to CTI for Notification Problems

October 12, 2010
Circulatory Technologies Inc. (CTI) was hit with a warning letter for failure to notify the FDA within 10 days of initiating a removal of one lot of its Bigger Better Bladder because of leakage problems. However, CTI did notify the FDA, but apparently not the right office, company President Yehuda Tamari said, as the company informed the main FDA office when it should have informed the district office. Tamari said all the issues were resolved before CTI received the July 12 warning letter, which was posted last month.
The GMP Letter