# FDA 483 - Cryobank America LLC - January 13, 2025

Source: https://www.keypedia.com/records/483/cryobank-america-llc/5390bf41-949c-4276-8f8a-76d6d0e8c923

> FDA 483 for Cryobank America LLC on January 13, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cryobank America LLC
- Inspection Date: 2025-01-13
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Cryobank America LLC, a reproductive tissue establishment in Arlington, TX, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies related to the accurate documentation of communicable disease testing for HCT/Ps and the lack of established procedures for the retention of donor eligibility records.

## Related Documents

- [483 - 2025-01-13](https://www.keypedia.com/records/483/cryobank-america-llc/58d657bc-f79d-42bc-93bc-7ccc201d9827)

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.keypedia.com/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

Company: https://www.keypedia.com/companies/cryobank-america-llc/558d6803-6a4d-4349-bd4f-9b09b691eaf0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab