Adaptimmune LLCApril 5, 2024

FDA 483 - Adaptimmune LLC - April 05, 2024

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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.

Company: Adaptimmune LLC
Inspection Date: April 5, 2024
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Elvia Angus, CSO
Anna R. Kwilas (investigator)
Viviana R. Ramirez

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ID · 3acfddd4-65a3-42ea-886c-a7887509cfaf