# FDA 483 - Diamond Institute for Infertility and Menopause - February 23, 2022

Source: https://www.globalkeysolutions.net/records/483/diamond-institute-for-infertility-and-menopause/45726846-9102-470f-814c-a4cdb461274f

> FDA 483 for Diamond Institute for Infertility and Menopause on February 23, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diamond Institute for Infertility and Menopause
- Inspection Date: 2022-02-23
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: The FDA inspected Diamond Institute for Infertility and Menopause in Millburn, NJ, and found significant deficiencies related to donor eligibility determination and screening for communicable diseases. The firm failed to properly screen donors with reactive test results or incomplete medical histories, shipped HCT/Ps without complete eligibility, and lacked adequate screening procedures, including for Zika Virus. These issues indicate a serious risk of transmitting communicable diseases through reproductive tissues.

## Related Officers

- [Supervisory](https://www.globalkeysolutions.net/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)
- [issuing_officer](https://www.globalkeysolutions.net/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

Company: https://www.globalkeysolutions.net/companies/diamond-institute-for-infertility-and-menopause/1529c7d6-f874-404d-a7eb-c7abdbdfef3c

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248