Reproductive Medicine Institute IVF, LLC – FDA Warning Letter, Jan 25, 2012

The FDA conducted an inspection of Reproductive Medicine Institute IVF, LLC from January 23-25, 2012, and documented significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to test for relevant communicable diseases [21 CFR 1271.85(a) and (b)(1)]**: Anonymous and directed reproductive donors lacked testing for HIV-1/HCV by NAT, anti-HBc, and HTLV-I/II (where appropriate). Examples cited include specific oocyte and semen donors. 2. **Failure to collect donor specimens within the required timeframe [21 CFR 1271.80(b)]**: A directed oocyte donor's specimen was collected outside the permissible window relative to oocyte recovery. 3. **Failure to screen donors by reviewing relevant medical records [21 CFR 1271.75]**: Records for directed semen and oocyte donors lacked documentation of a donor medical history interview. 4. **Failure to determine and document donor eligibility [21 CFR 1271.50(a)]**: Records for specific oocyte and semen donors did not include documentation of donor eligibility determination, including the responsible person's name and date. 5. **Failure