# FDA 483 - Virginia Center for Reproductive Medicine - September 20, 2023

Source: https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/bc4a01a0-fda9-4b91-a821-f8dcbe88a16b

> FDA 483 for Virginia Center for Reproductive Medicine on September 20, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Virginia Center for Reproductive Medicine
- Inspection Date: 2023-09-20
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: The FDA inspected Virginia Center for Reproductive Medicine, a reproductive human tissue establishment in Reston, VA, and identified significant deficiencies in their procedures for testing HCT/P donors. The firm failed to establish and maintain adequate donor testing protocols, including issues with testing timelines, required communicable disease agent tests (HIV, HCV, HBV, WNV, Zika), and the use of an obsolete donor medical history questionnaire. These findings indicate a lack of proper controls for ensuring donor eligibility and safety.

## Related Documents

- [WARNING_LETTER - 2013-06-12](https://www.globalkeysolutions.net/records/warning_letter/virginia-center-for-reproductive-medicine/f6875b07-afbb-4788-85ab-d4e32218bd26)
- [483 - 2019-02-25](https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/898ae4c0-17b6-4281-abf2-be12db608470)
- [WARNING_LETTER - 2019-02-25](https://www.globalkeysolutions.net/records/warning_letter/virginia-center-for-reproductive-medicine/e803287c-db02-4a1a-9466-ddbfc14354e0)
- [483 - 2021-10-29](https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/025348e0-e7bf-4346-9515-19990614692b)

## 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/virginia-center-for-reproductive-medicine/c5fac9a6-3648-4128-b608-a280d56ce07f

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