Purdue Pharma L.P. – FDA 483, Oct 5, 2023

An FDA inspection of Purdue Pharma L.P.'s corporate headquarters in Stamford, CT, revealed significant deficiencies in its post-marketing adverse drug experience reporting system. The firm lacked adequate written procedures for reporting non-15-day Alert reports and failed to submit thousands of serious and unexpected adverse drug experiences within the required 15 days. Additionally, individual adverse drug experiences were not consistently included in periodic safety reports, and numerous Individual Case Safety Reports (ICSRs) were submitted late.