FDA 483 - Celgene Corporation - April 24, 2013

An FDA inspection of Celgene Corporation's corporate headquarters in Berkeley Heights, NJ, revealed significant deficiencies in post-marketing adverse drug experience (ADE) reporting and annual report submissions. The firm failed to develop adequate written procedures for ADE surveillance and reporting, resulting in numerous late submissions of adverse event reports. Additionally, annual reports did not include status updates for all required post-marketing studies.