FDA 483 - Ariad Pharmaceuticals - May 31, 2017

An FDA inspection of ARIAD Pharmaceuticals, Inc. in Cambridge, MA, revealed significant deficiencies in their post-market reporting processes. The firm failed to timely report serious and unexpected adverse drug experiences, including cases of neoplasm progression and death, within the required 15 calendar days. Additionally, the company did not submit follow-up NDA-Field Alert Reports within three working days for drug product quality issues, such as incorrect tablet counts in Iclusig bottles.