# FDA 483 - Positive Steps Fertility, PLLC - August 16, 2022

Source: https://www.keypedia.com/records/483/positive-steps-fertility-pllc/53e6f2b2-2f3a-4d11-b125-1eea4df13ecc

> FDA 483 for Positive Steps Fertility, PLLC on August 16, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Positive Steps Fertility, PLLC
- Inspection Date: 2022-08-16
- Product Type: other
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Positive Steps Fertility, PLLC in Madison, MS, revealed significant deficiencies in their donor screening processes for reproductive tissues. The firm failed to adequately screen thirteen anonymous oocyte donors for communicable disease risk factors, specifically Zika virus. Additionally, the firm lacked established procedures for screening HCT/Ps for West Nile and Zika viruses, indicating a failure to ensure donor eligibility and protect recipients from potential disease transmission.

## Related Officers

- [Juanelma H. Palmer](https://www.keypedia.com/people/juanelma-h-palmer/db3e79b5-d2d4-46d8-a075-4674dbc8c3d0)

Company: https://www.keypedia.com/companies/positive-steps-fertility-pllc/591ec6ef-5aaf-4893-9203-1b2c921528cb

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea