# FDA 483 - Adaptimmune LLC - April 05, 2024

Source: https://www.keypedia.com/records/483/adaptimmune-llc/3acfddd4-65a3-42ea-886c-a7887509cfaf

> FDA 483 for Adaptimmune LLC on April 05, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Adaptimmune LLC
- Inspection Date: 2024-04-05
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Elvia Angus, CSO](https://www.keypedia.com/people/elvia-angus-cso/06ce9fc4-b58d-49bf-8274-0612f95a0ed0)
- [Viviana R. Ramirez](https://www.keypedia.com/people/viviana-r-ramirez/1d34f713-edc8-4776-ad70-28fcd59345de)
- [investigator](https://www.keypedia.com/people/anna-r-kwilas/c5c90f89-83e2-48a3-9ce7-efc7c9519d9f)

Company: https://www.keypedia.com/companies/adaptimmune-llc/6394510c-b8e5-4662-a4f9-e3f788e5adcb

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd