# FDA 483 - Resilience US, Inc - Unknown Date

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

> FDA 483 for Resilience US, Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience US, Inc
- 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

- [Sharmila Shrestha](https://www.keypedia.com/people/sharmila-shrestha/0a91aac0-76a5-4105-a23b-e0966f1aec0e)
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Company: https://www.keypedia.com/companies/resilience-us-inc/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