Westlake IVF, LLC – FDA Warning Letter, May 31, 2019

On September 30, 2019, the FDA issued a Warning Letter to Westlake IVF, LLC, following an inspection from May 20-31, 2019. The inspection revealed 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 determine and document donor eligibility based on screening and testing results for directed oocyte and semen donors. 2. Failure to test anonymous oocyte donors for West Nile Virus (WNV) Nucleic Acid Testing (NAT) during the June 1st-October 31st period. 3. Failure to screen reproductive cell/tissue donors for Zika virus (ZIKV) risk factors. 4. Failure to complete abbreviated donor screening procedures, specifically not documenting changes in medical history for anonymous oocyte donors between donations. 5. Failure to establish and maintain procedures for donor testing, screening, and eligibility, including not specifying WNV and ZIKV testing/screening in procedures, and missing HIV1/HCV/HBV NAT in an SOP and HBV NAT on a donor eligibility form.

The FDA acknowledged Westlake IVF's June 10, 2019, response and committed corrective actions, including new procedures and staff re-training. However, the FDA noted a discrepancy in the WNV testing period