FDA 483 - Swiss American CDMO, LLC - September 28, 2018

An FDA inspection of Swiss-American CDMO, LLC in Carrollton, TX, from September 26-28, 2018, identified a significant deficiency in the validation of software used within the firm's quality system. The firm failed to adequately validate its software, specifically by not executing operational qualification test scripts as stipulated in its own validation master plan and procedures. This indicates a serious deviation from established protocols for ensuring software suitability for its intended use.