# FDA 483 - Fairfax Cryobank Inc - Fairfax - March 20, 2019

Source: https://www.globalkeysolutions.net/records/483/fairfax-cryobank-inc-fairfax/1cc52cc9-c665-4c28-acb6-8c2b140f751d

> FDA 483 for Fairfax Cryobank Inc - Fairfax on March 20, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fairfax Cryobank Inc - Fairfax
- Inspection Date: 2019-03-20
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Fairfax Cryobank, Inc. in Fairfax, VA, a human reproductive tissue establishment, revealed significant deficiencies in donor eligibility processes. Observations included a failure to maintain complete documentation for donor eligibility determinations, inadequate screening of semen donors for communicable disease risks like Zika virus, and a lack of established procedures for determining donor eligibility. These issues indicate a need for improved controls in donor screening and record-keeping.

## Related Documents

- [483 - 2019-03-20](https://www.globalkeysolutions.net/records/483/fairfax-cryobank-inc-fairfax/262ff54f-9339-46c8-ac1b-18775d6c67df)
- [483 - 2023-08-24](https://www.globalkeysolutions.net/records/483/fairfax-cryobank-inc-fairfax/e4f205ca-2d76-4c78-be75-b412843248a3)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e