18HHS LLC – FDA 483, Jun 1, 2026

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.