The Fertility Partnership LLC – FDA Warning Letter, Mar 5, 2018

On May 24, 2018, the FDA issued Warning Letter #OBPO 18-04 to The Fertility Partnership LLC, following an inspection from February 21 to March 5, 2018. The inspection revealed deviations from 21 CFR Part 1271 regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to test donor specimens for relevant communicable disease agents [21 CFR 1271.85(a)]**: Examples include anonymous oocyte donors not tested for HIV-1, HCV, HBV, and WNV by NAT, or missing HBsAg testing. 2. **Failure to determine and document donor eligibility based on screening and testing results [21 CFR 1271.50(a)]**: Eligibility determinations were made before test results were available or without a responsible person's signature. 3. **Failure to screen donors for risk factors for relevant communicable diseases [21 CFR 1271.75(a)]**: The "Donor Medical History Interview Form" inadequately assessed Zika virus (ZIKV) exposure, failing to screen multiple donors for ZIKV. 4. **Failure to use FDA-licensed, approved, or cleared donor screening tests [21 CFR 1271.80(c)]