FDA 483 - TriRx Huntsville Pharmaceutical Services, LLC - June 15, 2026

TriRx Huntsville Pharmaceutical Services, LLC, a drug manufacturer in Huntsville, AL, was inspected and cited for multiple significant deficiencies. Observations included inadequate complaint handling, lack of validated cleaning procedures, unestablished test method accuracy, insufficient process validation, and improper equipment calibration. These issues indicate a systemic failure in maintaining a state of control over critical manufacturing and quality control processes.