FDA WARNING_LETTER - Louisville Reproductive Center - June 15, 2017

The FDA inspected Louisville Reproduction Center from June 7-15, 2017, and found significant deviations from HCT/P regulations (21 CFR Part 1271). The facility failed to adequately screen reproductive cell/tissue donors for communicable diseases per 21 CFR 1271.75(a). Specifically, several oocyte and semen donors were determined eligible despite missing required "Personal Health Inventory" or "Oocyte Donor Screening Questionnaire" forms. The screening forms also lacked questions for Zika Virus and West Nile Virus, and an outdated question regarding transfusions in the UK (omitting France) was identified.

Additionally, the facility failed to perform complete donor screening procedures within the previous six months for anonymous oocyte donors, as required by 21 CFR 1271.75(e). The FDA acknowledged the firm's June 19, 2017, response regarding oocyte donor screening but noted it did not address semen donor screening or the absence of a physical assessment for all donors. The letter reminds the firm of labeling requirements for cryopreserved embryos if used for donation. The FDA requires a written response within 15 working days detailing corrective actions and recurrence prevention. Failure to comply may result in further regulatory action.