# Oxford Biomedica (US), LLC – FDA 483

Source: https://www.keypedia.com/records/483/oxford-biomedica-us-llc/d87ed3f0-2ffe-45f3-8d91-d3653ebba1b7

> FDA 483 for Oxford Biomedica (US), LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxford Biomedica (US), LLC
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Resilience US, Inc, a Cell and Gene Therapy Contract Manufacturer in Durham, NC, revealed five observations. The firm was cited for inadequate procedures regarding deviation classification and trending, undefined retesting procedures for Out of Specifications, a deficient disinfectant efficacy study, and deficiencies in incoming component testing.

## Related Officers

- [Laura DeMaster](https://www.keypedia.com/people/laura-demaster/e3100cd3-a0fe-4d17-ae22-d5b516b5b25a)
- [investigator](https://www.keypedia.com/people/anna-r-kwilas/c5c90f89-83e2-48a3-9ce7-efc7c9519d9f)
- [Sharmila Shrestha](https://www.keypedia.com/people/sharmila-shrestha/0a91aac0-76a5-4105-a23b-e0966f1aec0e)
- [Jie He](https://www.keypedia.com/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)

Company: https://www.keypedia.com/companies/oxford-biomedica-us-llc/f99c09e6-18ac-4767-8250-1b9592416ea5

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