FDA 483 - Argenta US Manufacturing LLC - December 14, 2022

An FDA inspection of TriRx Shawnee, LLC, an animal and human drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results and customer complaints, lacked adequate procedures to prevent microbiological contamination in sterile products, and did not properly test components for parenteral drugs. These issues indicate a serious lack of adherence to good manufacturing practices.