483
Adaptimmune LLCAdaptimmune LLC – FDA 483, Apr 5, 2024
Record Details
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.
View Company Profile
ID · 3acfddd4-65a3-42ea-886c-a7887509cfaf
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.