FDA 483 - Upsher-Smith LLC - August 08, 2025

An FDA inspection of Upsher-Smith LLC identified significant deficiencies in their postmarketing adverse drug experience reporting. The firm failed to report several serious and unexpected adverse drug experiences to the FDA within the required 15-calendar-day timeframe, with delays extending over 300 days in some cases. Additionally, the firm lacked comprehensive written procedures for the surveillance and receipt of postmarketing adverse drug experiences, including those from social media, internal tracking systems, and contracted safety vendors.