# FDA 483 - Virginia Center for Reproductive Medicine - February 25, 2019

Source: https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/898ae4c0-17b6-4281-abf2-be12db608470

> FDA 483 for Virginia Center for Reproductive Medicine on February 25, 2019. 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: 2019-02-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA inspected Virginia Center for Reproductive Medicine in Reston, VA, and issued a Form 483 with seven observations, many of which were repeat deficiencies. The inspection revealed significant issues with donor screening for communicable diseases, improper donor eligibility determinations, and inadequate record-keeping for human cells, tissues, and cellular and tissue-based products (HCT/Ps). These findings highlight persistent non-compliance in critical areas related to donor safety and quality control.

## Related Documents

- [WARNING_LETTER - 2013-06-12](https://www.globalkeysolutions.net/records/warning_letter/virginia-center-for-reproductive-medicine/f6875b07-afbb-4788-85ab-d4e32218bd26)
- [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)
- [483 - 2023-09-20](https://www.globalkeysolutions.net/records/483/virginia-center-for-reproductive-medicine/bc4a01a0-fda9-4b91-a821-f8dcbe88a16b)

## Related Officers

- [Amy Malla](https://www.globalkeysolutions.net/people/amy-malla/1548a85d-df6e-4fa2-8c25-c9aafa322bbc)
- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)

Company: https://www.globalkeysolutions.net/companies/virginia-center-for-reproductive-medicine/c5fac9a6-3648-4128-b608-a280d56ce07f

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