FDA EIR - Avadel Pharmaceuticals PLC - April 24, 2019

A routine comprehensive surveillance inspection of Avadel Pharmaceuticals (USA) Inc. was conducted from April 22-24, 2019, at its Chesterfield, MO facility. The inspection focused on the company's Postmarketing Adverse Drug Experience (PADE) reporting operations for its four approved prescription drug products, aligning with FDA compliance program 7353.001. The review encompassed standard operating procedures, personnel interviews, safety data exchange agreements, electronic processes, and adverse event reports to ensure proper surveillance, receipt, evaluation, and submission of required PADE reports.

During the inspection, one instance was identified where a 15-day alert report was not submitted within the required timeframe. This was attributed to an initial misassessment of the event, which was subsequently corrected by the quality control unit and a medical reviewer. A deviation and Corrective and Preventive Action (CAPA) were completed by the firm and its contractor.

Significantly, no Form FDA 483 (Inspectional Observations) was issued, and the inspection was classified as "No Action Indicated" (NAI). While no specific violations necessitated immediate action, management was reminded during the close-out meeting of their overarching responsibility to comply with the Federal Food, Drug, and Cosmetic (FD&C) Act, with a general warning that failure to do so could result in future regulatory actions.