FDA 483 - TriRx Huntsville Pharmaceutical Services, LLC - April 01, 2022

TriRx Huntsville Pharmaceutical Services, LLC, a drug product manufacturer in Huntsville, AL, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate procedures to prevent objectionable microorganisms in drug products and a failure of the Quality Control Unit to properly investigate contamination sources and rejected materials. These issues indicate a serious lack of control over manufacturing processes and quality assurance.