AltaThera Pharmaceuticals LLC – FDA EIR, Jun 17, 2022

AltaThera Pharmaceuticals LLC underwent an FDA inspection from June 10-17, 2022, focusing on Postmarketing Adverse Drug Experience (PADE) reporting for its sole product, Sotalol Injection. The inspection identified four significant observations, leading to the issuance of a Form FDA 483. Primary violations included the company's failure to maintain adverse drug experience records for the required 10-year period, with specific annual reports and source documentation preceding September 2021 being unavailable. Additionally, AltaThera had not developed complete written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. These procedures lacked coverage for preparing and submitting Periodic Adverse Drug Experience Reports (PADERs), handling data received outside business hours, and documenting follow-up information. Further issues identified were the late submission of several annual periodic adverse drug experience reports and annual reports, which are required to be submitted within 60 days of the product's anniversary approval date. These findings indicate a lack of robust internal controls and oversight regarding critical pharmacovigilance responsibilities. The inspection was conducted under the regulatory framework of FDA's Postmarketing Adverse Drug Experience (PADE) Reporting compliance program (7353.001) and relevant sections of 21 CFR Part 314. AltaThera management indicated they would provide a written response to the observations. The FDA informed the company that observed conditions might be considered violations, potentially leading to legal sanctions such as seizure, injunction, or civil money penalties, pending further agency review and final classification of the inspection.