FDA 483 - Indivior Manufacturing LLC - January 18, 2024

Indivior Manufacturing LLC in Raleigh, NC, a pharmaceutical contract manufacturer, was cited for multiple significant deficiencies during an FDA inspection from January 9-18, 2024. Observations included inadequate validation of aseptic processes, failure to follow written procedures, improper equipment calibration and maintenance, and a lack of thorough investigation into discrepancies and batch failures. Additionally, the quality control unit did not fully adhere to its responsibilities, and employees lacked required training, with some issues being repeat observations.