Amerigen Pharmaceuticals Inc. – FDA EIR, Jul 27, 2017

An FDA inspection of Amerigen Pharmaceuticals Inc. was conducted from July 24-27, 2017, focusing on the company's Postmarketing Adverse Drug Experience (PADE) surveillance, receipt, evaluation, processing, and reporting system. This was the first inspection of the New Jersey-based generic pharmaceutical distributor, carried out under the regulatory framework of Compliance Program Guide 7353.001, "Postmarketing Adverse Drug Experience (PADE) Reporting Inspections," and 21 CFR 314.80(b). The primary violation identified, documented in an FDA-483, was the absence of adequate written procedures for handling postmarketing adverse drug experiences. Specifically, the firm's existing Standard Operating Procedures (SOPs) failed to comprehensively address the surveillance of adverse drug experiences, including how information from various sources is received, identified, and reconciled. Procedures also lacked sufficient detail for evaluating adverse drug experiences for seriousness, expectedness, and reportability, critical for determining if they qualify as 15-day Alert reports. Furthermore, the procedures did not ensure that Individual Case Safety Reports (ICSRs) were submitted electronically in the format required by the FDA. As required actions, management was urged to review FDA guidance documents, ensure all employees are adequately trained on adverse event reporting, develop SOPs that clearly differentiate product complaint handling from adverse event processing, and improve monitoring of outsourced pharmacovigilance activities. Amerigen Pharmaceuticals Inc. acknowledged the findings and committed to making necessary changes, with a 15-business-day deadline to respond to the FDA-483.