# FDA 483 - Virginia Center for Reproductive Medicine - October 29, 2021

Source: https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/025348e0-e7bf-4346-9515-19990614692b

> FDA 483 for Virginia Center for Reproductive Medicine on October 29, 2021. 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: 2021-10-29
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: The FDA inspected Virginia Center for Reproductive Medicine in Reston, VA, and found significant issues with donor screening and product labeling. The firm failed to adequately screen HCT/P donors for communicable disease risk factors, including Zika virus, and used deficient medical history interview forms. Additionally, HCT/Ps from ineligible donors with reactive tests for syphilis and Hepatitis B were not properly labeled with required warning statements.

## 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 - 2023-09-20](https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/bc4a01a0-fda9-4b91-a821-f8dcbe88a16b)

## Related Officers

- [Kenneth L. Smalls](https://www.globalkeysolutions.net/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)
- [Richard J. Bashay](https://www.globalkeysolutions.net/people/richard-j-bashay/ce50702d-1f5b-42c5-b50a-88bb43cba196)

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