# FDA 483 - Safari Stem Cell, LLC - January 10, 2025

Source: https://www.keypedia.com/records/483/safari-stem-cell-llc/ed813b6d-d91a-46d6-bd21-23cba8cd8fcd

> FDA 483 for Safari Stem Cell, LLC on January 10, 2025. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safari Stem Cell, LLC
- Inspection Date: 2025-01-10
- Product Type: veterinary
- Office Name: Dallas District Office
- Summary: Safari Stem Cell, LLC, an animal stem cell product manufacturer in League City, TX, was cited for significant deficiencies during an FDA inspection. The firm failed to establish adequate production controls, sterility testing, product specifications, and environmental monitoring for its culture-expanded allogeneic adipose-derived cell products. Many of these issues are repeat observations, indicating persistent non-compliance and a prior Warning Letter.

## Related Documents

- [483 - 2023-05-04](https://www.keypedia.com/records/483/safari-stem-cell-llc/46f9ba9a-3cae-49f5-a746-7461d369c2bc)
- [WARNING_LETTER - 2023-05-04](https://www.keypedia.com/records/warning_letter/safari-stem-cell-llc/44cc4b7d-cb32-4143-96b2-ec4b8f21db43)

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [investigator](https://www.keypedia.com/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.keypedia.com/companies/safari-stem-cell-llc/c58ed861-2a10-466a-9032-3e7d418c51d6

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