FDA EIR - APCER Life Sciences, Inc. - June 21, 2016

An FDA Post-Marketing Adverse Drug Experience (PADE) inspection of APCER Life Sciences, Inc. in Princeton, NJ, was conducted from June 17-21, 2016. The inspection, guided by regulatory framework 7353.001, evaluated APCER's role as a third-party pharmacovigilance service provider, handling activities like case intake, processing, and reporting for pharmaceutical clients.

Key issues identified included an incomplete technical agreement with a client, which omitted specific products for which APCER was performing services. The inspection also noted instances of late submissions for 15-day Alert reports and two Postmarketing Adverse Drug Experience Reports (PADERs) due to an initial formatting error. Furthermore, crucial safety-related correspondence and final MedWatch reports were stored in individual employee email accounts rather than a centralized safety database. A significant finding was the inadequate training of non-pharmacovigilance personnel regarding adverse drug experience reporting.

APCER management committed to several corrective actions: updating the client contract to include all relevant products, ensuring continued timely and appropriate report submissions, centralizing the storage of all safety records and correspondence within their safety database for improved accessibility, and providing comprehensive training to all employees on recognizing and handling adverse drug experiences.