# FDA WARNING_LETTER - Reproductive Medicine Institute IVF, LLC - January 25, 2012

Source: https://www.keypedia.com/records/warning_letter/reproductive-medicine-institute-ivf-llc/c4a627d4-7c1d-45ff-946c-3dc66ba5f0af

> FDA WARNING_LETTER for Reproductive Medicine Institute IVF, LLC on January 25, 2012. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Reproductive Medicine Institute IVF, LLC
- Inspection Date: 2012-01-25
- Product Type: Biologics
- Office Name: Florida District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/reproductive-medicine-institute-ivf-llc/e064b405-b1ec-4d17-9236-2c14a38880ba

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9