FDA 483 - Coupler LLC - April 27, 2018

Coupler Enterprises, a contract drug repackager in Warrington, PA, was cited for significant deficiencies during an FDA inspection. The observations highlight a lack of fundamental quality control systems, including no designated quality unit, inadequate equipment cleaning and maintenance procedures, and an absence of a stability testing program for repackaged drugs. These issues indicate a severe lack of control over critical manufacturing and packaging processes.