FDA 483 - Adaptimmune LLC - April 05, 2024

Adaptimmune, LLC. in Philadelphia, PA, a cell therapy manufacturer, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to adequately address root causes in deviation investigations, exhibited insufficient incoming component testing, and had poor documentation practices for manufacturing deviations. Additionally, procedures for retesting out-of-specification results and trending deviations were found to be inadequate.