FDA 483 - Exela Pharma Sciences LLC - November 21, 2014

On November 17-21, 2014, the FDA inspected Exela Pharma Sciences, LLC, an outsourcing facility located at 1325 William White Place, Lenoir, NC. The inspection, conducted by Consumer Safety Officers Noreen Muniz and Brett Weed, identified deficiencies in procedures designed to prevent microbiological contamination of sterile drug products.

Specifically, media fills, as per procedure QA012-02, lacked documented evidence to justify the number and frequency of simulated interventions, did not include simultaneous routine activities, and failed to fully document media temperature before filling.

A smoke study video (document# 2010-PQ-123, 08/19/2010) for the Grade A Sterile Area Filling Machine was deemed inadequate. It used limited smoke, did not confirm uni-directional flow within the filling line, omitted operator interventions (especially simultaneous or line set-up activities), failed to follow smoke patterns near wall air returns, and showed operators performing slow movements inconsistent with routine operations.

Furthermore, operators did not consistently follow procedure OP006-02, "Behavior in Manufacturing Clean Rooms." Observations on November 17, 2014, included fast, uncontrolled movements, abrupt opening of enclosures, and simultaneous interventions. A July 2014 media fill video showed operators moving with uncontrolled movements, talking, blocking air returns, and performing non-controlled interventions in the Grade