FDA 483 - Zhang Medical P.C. d/b/a New Hope Fertility Center - February 22, 2024

Zhang Medical P.C. d/b/a New Hope Fertility Center in New York, NY, was cited for deficiencies in its reproductive human tissue operations. The inspection revealed failures in determining HCT/P donor eligibility, including inadequate screening for communicable disease risks such as Bovine Spongiform Encephalopathy. Additionally, the firm lacked established procedures for screening directed semen donors and failed to properly label HCT/Ps from donors with incomplete screening.