FDA 483 - New Directions Fertility Center - April 02, 2025

An FDA inspection of New Directions Fertility Center in Gilbert, AZ, revealed significant deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) program. The firm failed to properly determine donor eligibility, conduct timely and comprehensive donor screening and testing, and maintain adequate procedures and records for HCT/P donors. These issues indicate a lack of control over critical aspects of donor suitability and record-keeping.