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

Source: https://www.globalkeysolutions.net/records/483/cryobank-america-llc/58d657bc-f79d-42bc-93bc-7ccc201d9827

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

---

## Details

- Record Type: 483
- Company Name: Cryobank America LLC
- Inspection Date: 2025-01-13
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Cryobank America LLC, a reproductive tissue establishment in Arlington, TX, was inspected by the FDA. The inspection revealed two observations primarily concerning inadequate record-keeping and issues with communicable disease testing documentation. Specifically, the firm failed to include required statements about CLIA certification for testing laboratories and lacked proper procedures for record retention.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9