# FDA 483 - CellRight Technologies LLC - July 25, 2024

Source: https://www.globalkeysolutions.net/records/483/cellright-technologies-llc/9aa55e16-3ec0-4163-b198-b17130bb6472

> FDA 483 for CellRight Technologies LLC on July 25, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellRight Technologies LLC
- Inspection Date: 2024-07-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: CellRight Technologies LLC, a human tissue processor in Universal City, TX, received an FDA Form 483 citing significant deficiencies. The inspection revealed failures in validating manufacturing processes for skin graft products, inadequate testing of components, and non-adherence to procedures designed to prevent microbiological contamination. These observations indicate a lack of robust quality controls for their drug products.

## Related Documents

- [483 - 2019-03-15](https://www.globalkeysolutions.net/records/483/cellright-technologies-llc/61c10834-8fb6-4d80-8fa8-d6f8219d616a)

## Related Officers

- [Esther A. Ofori](https://www.globalkeysolutions.net/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/cellright-technologies-llc/94f7bd83-92c4-4c6c-b79d-0540ad99f903

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab