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

Source: https://www.keypedia.com/records/warning_letter/utah-cord-bank-llc/5d33db14-c1ce-447b-b250-13c21c72efb6

> FDA WARNING_LETTER for Utah Cord Bank LLC on February 11, 2021. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Utah Cord Bank LLC
- Inspection Date: 2021-02-11
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division II
- Summary: 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)):**

## Related Documents

- [483 - 2021-02-11](https://www.keypedia.com/records/483/utah-cord-bank-llc/011fe5b1-d69b-4265-9af3-ce95a4fd380c)
- [WARNING_LETTER - 2021-02-11](https://www.keypedia.com/records/warning_letter/utah-cord-bank-llc/9460479c-44df-4bb6-9d0c-fe83dcd4b23f)
- [483 - 2023-01-06](https://www.keypedia.com/records/483/utah-cord-bank-llc/e0491819-2b53-4a61-b1a1-523777a8aa94)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.keypedia.com/companies/utah-cord-bank-llc/743c0464-dbbc-49bb-aa26-68e0f9dc8db6

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-ii/a54ce137-326d-424b-ab5e-d8b8c28e8b47