FDA WARNING_LETTER - Utah Cord Bank LLC - February 11, 2021

On May 11, 2021, the FDA issued a Warning Letter to Utah Cord Bank, LLC, following an inspection from February 1-11, 2021. The inspection revealed significant deviations from Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations (21 CFR Part 1271), applicable to HCT/Ps recovered between May 25, 2005, and February 11, 2021.

Key violations include: 1. **Failure to Validate Processes (21 CFR 1271.230(a)):** The firm failed to validate manufacturing processes, including microbiological testing, to ensure prevention of contamination and communicable disease transmission. 2. **Inadequate Environmental Monitoring (21 CFR 1271.195(c)):** Environmental conditions were not adequately monitored where HCT/Ps were exposed to the environment during processing, potentially causing contamination. 3. **Lack of Established Procedures (21 CFR 1271.180(a)):** The firm failed to establish and maintain procedures for critical operations, including facilities, environmental control, equipment, supplies/reagents, processing, labeling, storage, and distribution. 4. **Failure to Maintain Complete Records (21 CFR 1271.270(a)):**