FDA 483 - Purdue Pharma L.P. - March 29, 2019

Purdue Pharma, L.P.'s corporate headquarters in Stamford, CT, was cited for failing to report serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. The firm did not report 115 such cases between 2011 and 2018, involving products marketed outside the United States but containing active moieties similar to those marketed domestically. This indicates a significant deficiency in the company's safety reporting procedures.