FDA EIR - Amerigen Pharmaceuticals Inc. - January 18, 2019

An FDA surveillance Postmarketing Adverse Drug Experience (PADE) inspection of Amerigen Pharmaceuticals Inc. was conducted from January 17-18, 2019, in Lyndhurst, NJ. This inspection, carried out under CP 7353.001, focused on the company's adverse drug experience reporting processes. While no Form FDA 483, Inspectional Observations, was issued, a general discussion with management highlighted several critical areas for improvement.

Key issues included an inaccurate written procedure (SOP US85-SOP-004) stating the electronic reporting of MedWatch form 3500A, despite actual submissions being made via alternative electronic gateways (E2B/SRP). Furthermore, the SOP lacked specific procedures on the required number of follow-ups with reporters for adverse events. Inadequate training was also identified, with some employees, including an Executive Assistant, unfamiliar with Adverse Drug Experiences and untrained in their handling.

This was Amerigen's second PADE inspection; the previous 2017 inspection also resulted in observations regarding insufficient written procedures for PADE surveillance, receipt, evaluation, and reporting. Management acknowledged the current findings and agreed to review and amend their SOPs to reflect accurate electronic reporting methods, include follow-up protocols, and ensure all relevant employees receive comprehensive training on handling adverse drug experiences.