FDA 483 - New Directions Fertility Center - April 02, 2025
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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.
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ID · c69fac08-71ba-4139-9e4c-fc12c760c602