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

Source: https://www.globalkeysolutions.net/records/483/new-directions-fertility-center/c69fac08-71ba-4139-9e4c-fc12c760c602

> FDA 483 for New Directions Fertility Center on April 02, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Directions Fertility Center
- Inspection Date: 2025-04-02
- Product Type: other
- Office Name: Denver District Office
- Summary: 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.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/new-directions-fertility-center/8bff9de3-9396-45b5-908a-04114f8666eb

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face