FDA 483 - Arizona Reproductive Medicine Specialists - June 30, 2025

An FDA inspection of Arizona Reproductive Medicine Specialists in Phoenix, AZ, revealed significant deficiencies in donor eligibility determination and HCT/P handling. The firm failed to adequately test and screen donors for communicable diseases, maintain proper records, and apply required warning labels to reproductive tissues. These issues raise concerns about the safety and quality of the human cells, tissues, and cellular and tissue-based products (HCT/Ps) provided.