FDA 483 - FillTech USA, LLC - April 14, 2022

An FDA inspection of Filltech USA, LLC in Rockwell, NC, revealed significant deficiencies in equipment qualification, computer system controls, and raw material storage conditions. The firm failed to qualify a filling line and validate its water system, allowed test data deletion from its FTIR system, and lacked temperature/humidity mapping for raw material storage. These issues indicate a lack of appropriate controls to ensure drug product quality and purity.