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

An FDA inspection of Zhang Medical P.C. d/b/a New Hope Fertility Center in New York revealed significant deficiencies in both human cell, tissue, and cellular and tissue-based product (HCT/P) operations and drug product manufacturing. The firm failed to properly determine and document donor eligibility, conduct adequate donor screening and testing, and maintain accurate records for HCT/Ps. Additionally, the facility lacked validated aseptic processes, written procedures, sterility testing, and release criteria for its adipose tissue cellular product, indicating serious quality control issues.