# FDA 483 - Fairfax Cryobank Inc - Fairfax - August 24, 2023

Source: https://www.globalkeysolutions.net/records/483/fairfax-cryobank-inc-fairfax/e4f205ca-2d76-4c78-be75-b412843248a3

> FDA 483 for Fairfax Cryobank Inc - Fairfax on August 24, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fairfax Cryobank Inc - Fairfax
- Inspection Date: 2023-08-24
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: Fairfax Cryobank, Inc. in Fairfax, VA, was cited for distributing semen specimens from donors with incomplete Zika virus (ZIKV) screening before obtaining necessary exemptions or alternatives. This practice occurred over several years, despite repeated FDA instructions to quarantine such specimens until an exemption was granted. The firm distributed HCT/Ps that were not fully screened and released them without proper authorization.

## Related Documents

- [483 - 2019-03-20](https://www.globalkeysolutions.net/records/483/fairfax-cryobank-inc-fairfax/262ff54f-9339-46c8-ac1b-18775d6c67df)
- [483 - 2019-03-20](https://www.globalkeysolutions.net/records/483/fairfax-cryobank-inc-fairfax/1cc52cc9-c665-4c28-acb6-8c2b140f751d)

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/fairfax-cryobank-inc-fairfax/ce331f0e-c4b9-40b8-9182-1709e5126e9f

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64