# FDA 483 - CCRM Fertility Northern Virginia - February 11, 2022

Source: https://www.globalkeysolutions.net/records/483/ccrm-fertility-northern-virginia/b2aa70b8-4b51-4497-a6e3-59e7a7c4efad

> FDA 483 for CCRM Fertility Northern Virginia on February 11, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CCRM Fertility Northern Virginia
- Inspection Date: 2022-02-11
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: CCRM Fertility Northern Virginia, a reproductive human tissue establishment in Vienna, VA, was cited for deficiencies in its donor screening processes. The inspection revealed that donor medical history interview questionnaires and established procedures for HCT/P donor screening used gender-specific language for Zika Virus risk factors, failing to adequately screen all potential donors for communicable diseases. This indicates a significant oversight in ensuring comprehensive donor eligibility.

## 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/ccrm-fertility-northern-virginia/8248ecf4-5db8-461d-9e5b-1e8956ecd8a6

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