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

Source: https://www.keypedia.com/records/483/arizona-reproductive-medicine-specialists/c1e1a2ec-845a-4bfe-a80e-087e1209a7d0

> FDA 483 for Arizona Reproductive Medicine Specialists on June 30, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arizona Reproductive Medicine Specialists
- Inspection Date: 2025-06-30
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.keypedia.com/companies/arizona-reproductive-medicine-specialists/93cd408a-190c-4f09-8fcc-f90ac3513abf

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6