FDA 483 - Integrated Commercialization Solutions LLC - July 15, 2019

Integrated Commercialization Solutions LLC, a repacker/relabeler in Brooks, KY, was cited for significant deficiencies in its quality control unit and complaint handling processes. The inspection revealed a lack of written procedures and qualification for visual inspection of finished products, as well as inadequate investigation and timely resolution of non-conformances and customer complaints. These issues indicate a systemic failure to ensure product quality and compliance.