FDA WARNING_LETTER - Conceive Fertility Center - June 13, 2025

The FDA issued a Warning Letter to Conceive Fertility Center following an inspection conducted from June 6 to June 13, 2025. The inspection documented significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps), specifically Title 21, Code of Federal Regulations Part 1271. Key issues included the failure to adequately screen reproductive cell donors for risk factors for relevant communicable diseases, with donor medical history forms missing critical questions, timeframes, or deferral periods for conditions like hepatitis, West Nile Virus, syphilis, and specific travel or transfusion histories. The center also failed to correctly identify and deem ineligible donors with identified risk factors, and improperly determined donor eligibility before all communicable disease test results were received. Further violations involved collecting donor specimens for testing outside the required timeframe and inadequacies in donor records, such as not stating reasons for ineligibility or fully listing and interpreting test results. A notable issue was the failure to establish and maintain adequate procedures for donor eligibility determination, which was identified as a repeat violation. The FDA found the center's initial response to these observations to be insufficient. Conceive Fertility Center is required to take prompt corrective action, prevent recurrence of these violations, and provide a detailed written response within fifteen working days. Additionally, HCT/Ps from donors with incomplete eligibility determinations must be quarantined.