FDA WARNING_LETTER - Virginia Center for Reproductive Medicine - June 12, 2013

The FDA conducted an inspection of Virginia Center for Reproductive Medicine from April to June 2013, documenting significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to determine donor ineligibility:** Donors with reactive screening tests for communicable diseases (e.g., HIV, HBc, HTLV-IIII) were not deemed ineligible, and their semen was still recovered. 2. **Failure to determine donor ineligibility based on risk factors:** Donors with risk factors (e.g., sex with other men, extensive residence in Europe during specific periods) were not determined ineligible. 3. **Improper labeling of HCT/Ps from ineligible donors:** HCT/Ps from donors with reactive tests or risk factors were not prominently labeled with "Biohazard" or appropriate warning statements. 4. **Failure to determine and document donor eligibility:** Eligibility determinations were not performed for several donors, or were made without reviewing complete screening/testing results. 5. **Failure to test for communicable diseases:** An anonymous oocyte donor was determined eligible and allowed to donate without required communicable disease testing. 6. **Failure to screen donors:** Several donors lacked documented medical history interviews or physical examinations. 7. **Inadequate summary of records:** Summaries accompanying H