# FDA 483 - Utah Cord Bank LLC - January 06, 2023

Source: https://www.keypedia.com/records/483/utah-cord-bank-llc/e0491819-2b53-4a61-b1a1-523777a8aa94

> FDA 483 for Utah Cord Bank LLC on January 06, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Utah Cord Bank LLC
- Inspection Date: 2023-01-06
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Utah Cord Bank LLC in Sandy, UT, revealed significant deficiencies in the control of storage areas for human umbilical cord blood and tissue products. The firm lacked an inventory system and corresponding Standard Operating Procedures to prevent mix-ups, contamination, and improper distribution of these critical HCT/Ps. This indicates a serious lack of control over product accountability and storage conditions.

## 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/5d33db14-c1ce-447b-b250-13c21c72efb6)
- [WARNING_LETTER - 2021-02-11](https://www.keypedia.com/records/warning_letter/utah-cord-bank-llc/9460479c-44df-4bb6-9d0c-fe83dcd4b23f)

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

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

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face