FDA 483 - Zhang Medical P.C. d/b/a New Hope Fertility Center - November 30, 2021

Zhang Medical P.C. d/b/a New Hope Fertility Center in New York was cited for significant deficiencies in its human cells, tissues, and cellular and tissue-based products (HCT/P) operations, particularly concerning donor eligibility determination, screening for communicable diseases, and proper labeling of tissues. Additionally, the firm failed to establish adequate aseptic processing validation, written procedures, sterility testing, and release criteria for its autologous adipose tissue derived cellular products used for ovarian rejuvenation, indicating severe quality control and regulatory compliance issues.