FDA 483 - AltaThera Pharmaceuticals LLC - June 17, 2022

Alta'Thera Pharmaceuticals LLC, a corporate headquarters in Chicago, was inspected regarding its postmarketing adverse drug experience processes. The inspection revealed significant deficiencies, including failures to maintain required records for 10 years and incomplete written procedures for adverse event reporting. Additionally, the firm repeatedly failed to submit annual periodic adverse drug experience reports for Sotalol Hydrochloride Injection within the required timeframe.