# FDA 483 - CellSure, L3C - December 08, 2023

Source: https://www.keypedia.com/records/483/cellsure-l3c/407a6b6a-0e0a-4c9b-a366-207c155e5fc4

> FDA 483 for CellSure, L3C on December 08, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellSure, L3C
- Inspection Date: 2023-12-08
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: An FDA inspection of Cellsure, L3C in Salt Lake City, UT, a stem cell own-label distributor, revealed significant deficiencies in their handling of human placenta and umbilical cord tissue. The firm failed to properly label HCT/Ps positive for communicable diseases, lacked adequate donor screening procedures, and had not established essential quality control, warehousing, distribution, or stability testing programs. Several of these critical issues were repeat observations, indicating persistent non-compliance.

## Related Documents

- [483 - 2021-08-02](https://www.keypedia.com/records/483/cellsure-l3c/8b419050-b96a-4491-9043-fb9cd663802d)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/cellsure-l3c/6133765e-3818-4bbf-8871-962046a40e8c

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d