# FDA 483 - CellRight Technologies LLC - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/cellright-technologies-llc/61c10834-8fb6-4d80-8fa8-d6f8219d616a

> FDA 483 for CellRight Technologies LLC on March 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellRight Technologies LLC
- Inspection Date: 2019-03-15
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of CellRight Technologies LLC in Universal City, TX, identified a significant deviation related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). The firm failed to report a deviation where an expired serology testing tube was used for a donor whose tissue products were subsequently distributed. This indicates a lapse in compliance with Current Good Tissue Practice (CGTP) reporting requirements.

## Related Documents

- [483 - 2024-07-25](https://www.globalkeysolutions.net/records/483/cellright-technologies-llc/9aa55e16-3ec0-4163-b198-b17130bb6472)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/everard-a-irish/840ad8d1-1e8a-4ade-9b3b-64f654754d17)
- [Supervisory](https://www.globalkeysolutions.net/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9