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

Source: https://www.globalkeysolutions.net/records/warning_letter/virginia-center-for-reproductive-medicine/e803287c-db02-4a1a-9466-ddbfc14354e0

> FDA WARNING_LETTER 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: WARNING_LETTER
- Company Name: Virginia Center for Reproductive Medicine
- Inspection Date: 2019-02-25
- Product Type: Biologics
- Office Name: Division of Biological Products Operations I
- Summary: The FDA issued a Warning Letter to Virginia Center for Reproductive Medicine following an inspection from February 13-25, 2019, which revealed significant deviations from HCT/P regulations (21 CFR Part 1271). Key violations include: failure to test anonymous oocyte donors for relevant communicable diseases (HIV-1/2, hepatitis B/C, syphilis, gonorrhea, chlamydia) [21 CFR 1271.85(a)]; inadequate donor screening questionnaires missing critical risk factors [21 CFR 1271.75(a)(1)]; failure to deem ineligible donors with identified risk factors [21 CFR 1271.75(d)]; and failure of a responsible person to properly determine and document donor eligibility based on complete screening and testing [21 CFR 1271.50(a)]. Additionally, the firm failed to provide summaries of records accompanying HCT/Ps that list and interpret all communicable disease test results, specifically omitting West Nile Virus (WNV) testing [21 CFR 1271.55(b)(2)].

The FDA noted that a previous inspection in 2013 resulted in a Warning Letter for similar violations, indicating a failure to implement effective corrective actions. The firm's March 4, 2019, response to the current inspection was deemed inadequate, with revised forms still containing errors or omissions

## 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)
- [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

- [Program Division Director](https://www.globalkeysolutions.net/people/elizabeth-a-waltrip/e11f7ba9-20f9-40f7-a44b-41629c6b53b0)
- [Cherlita Honeycutt](https://www.globalkeysolutions.net/people/cherlita-honeycutt/62b9e946-6334-491b-ab5a-e8094149662d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-biological-products-operations-i/171e538c-a14a-4bea-ab7e-a7d8dd2e79b5