# FDA 483 - Arizona Center for Reproductive Endocrinology & Infertility - June 28, 2023

Source: https://www.globalkeysolutions.net/records/483/arizona-center-for-reproductive-endocrinology-infertility/a55eee0c-abfe-47af-8646-8cc251ccd110

> FDA 483 for Arizona Center for Reproductive Endocrinology & Infertility on June 28, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arizona Center for Reproductive Endocrinology & Infertility
- Inspection Date: 2023-06-28
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Arizona Center for Reproductive Endocrinology & Infertility in Tucson, AZ, and found significant deficiencies in their donor screening and testing procedures for reproductive tissues. Observations included using non-FDA-approved tests, inadequate donor medical screening, improper specimen collection timing, and failures in record-keeping and procedure documentation for communicable disease risks. Several observations were repeats, indicating persistent issues with compliance.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)
- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.globalkeysolutions.net/companies/arizona-center-for-reproductive-endocrinology-infertility/d577485b-c5db-4319-984f-fb5a2f3f2c57

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