FDA 483 - WestRock Converting, LLC - September 12, 2025

During an inspection, WestRock Converting, LLC, an OTC Repacker in Ridgeway, VA, was cited for failing to store drug products under appropriate temperature conditions. The firm's temperature mapping studies were found to be inadequate, drug products were stored outside mapped and monitored locations, and there was no scientific rationale for the placement of temperature data loggers in the warehouse. These deficiencies indicate a significant risk to the identity, strength, quality, and purity of the drug products.