# FDA 483 - Stem Cell Cryo Bank, LLC / SFBMSCTI - May 01, 2025

Source: https://www.globalkeysolutions.net/records/483/stem-cell-cryo-bank-llc-sfbmscti/76efbe22-7916-431b-9ae3-bb1406317c46

> FDA 483 for Stem Cell Cryo Bank, LLC / SFBMSCTI on May 01, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stem Cell Cryo Bank, LLC / SFBMSCTI
- Inspection Date: 2025-05-01
- Product Type: biologics
- Office Name: Florida District Office
- Summary: An FDA inspection of Stem Cell Cryo Bank, LLC in Deerfield Beach, FL, a human umbilical cord blood establishment, revealed two significant observations. The firm failed to establish procedures to validate and approve processes, specifically the aseptic process for human umbilical cord blood units. Additionally, the quality program lacked procedures for investigating HCT/P deviations, including positive processing samples.

## Related Officers

- [Sergio E. Delgado](https://www.globalkeysolutions.net/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)

Company: https://www.globalkeysolutions.net/companies/stem-cell-cryo-bank-llc-sfbmscti/cb8383ee-f79d-4560-9c16-b0b432a8f227

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9