# 18HHS LLC – FDA 483, Jun 1, 2026

Source: https://www.keypedia.com/records/483/18hhs-llc/5a28459f-1716-45df-b03d-9afe8848fbab

> FDA 483 for 18HHS LLC on June 01, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 18HHS LLC
- Inspection Date: 2026-06-01
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of 18HHS LLC in Houston, TX, identified significant deficiencies related to the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly label HCT/Ps from ineligible donors, those not requiring donor eligibility determination, and those intended for autologous use, with appropriate warning statements such as biohazard legends and communicable disease risk warnings. These issues indicate a serious lack of control over product identification and patient safety information.

## Related Officers

- [Elyshia Q. Danaher](https://www.keypedia.com/people/elyshia-q-danaher/73046c15-abb1-431e-8a76-59c7e8c1604a)
- [Ashleigh M. Robertson](https://www.keypedia.com/people/ashleigh-m-robertson/b9f909fe-54cf-42c8-82cd-0fcb7b76e78c)

Company: https://www.keypedia.com/companies/18hhs-llc/080e3f97-ff79-491a-a824-e33814e7d25d

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