Zhang Medical P.C. d/b/a New Hope Fertility Center – FDA Warning Letter, Nov 30, 2021

The FDA issued a Warning Letter to Zhang Medical P.C. dba New Hope Fertility Center following an inspection from November 1-30, 2021, which revealed significant deviations from human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations (21 CFR Part 1271). Key violations included failure to determine ineligible donors with Zika virus risk factors, determining donor eligibility before receiving test results, and inadequate documentation of donor eligibility and reasons for ineligibility. The firm also failed to properly screen donors for communicable disease agents, including an incomplete Zika screening list and missing questionnaire responses, and did not collect donor specimens at the required times.

Furthermore, the FDA found the firm's proposed corrective actions, particularly regarding HCT/P labeling procedures, inadequate. Concerns were raised about incorrect donor designations for sexually-intimate partners, lack of explanation for untested oocyte donors, and inaccurate labeling for autologous donors, all violating 21 CFR 1271.50 and 1271.90(c). A deficiency in the Donor Medical History Interview Questionnaire's Zika screening question was also noted. The letter highlighted that many violations were recurrences from a 2014 inspection, indicating ineffective previous corrective actions. The firm must promptly correct all violations, quarantine HCT/Ps with incomplete eligibility determinations, and respond within 15 working days detailing comprehensive corrective and preventive actions to avoid further regulatory action.