Green Valley Fertility Partners – FDA Warning Letter, May 14, 2025

The FDA issued a Warning Letter to Green Valley Fertility Partners following an inspection conducted from May 8 to May 14, 2025. The inspection revealed significant violations of regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) outlined in 21 CFR Part 1271. Key issues included the repeated failure to test specimens from reproductive donors for relevant communicable disease agents, such as West Nile Virus, and inadequate donor screening due to an incomplete infectious disease questionnaire lacking crucial questions on various health risks including hepatitis, drug use, and Creutzfeldt-Jakob Disease. The firm also failed to appropriately determine donor eligibility, as some donors with identified risk factors were deemed eligible, and eligibility was frequently determined before all required testing and physical examinations were complete. Additionally, Green Valley Fertility Partners failed to maintain proper record anonymity for anonymous donors by including personal information on accompanying records and using first names in identification codes. The FDA requires the company to promptly correct these violations, implement a comprehensive corrective action plan, and submit a detailed written response within 15 working days outlining how they will achieve compliance and prevent recurrence.