# FDA 483 - Elite IVF & Fertility Solutions LLC - March 28, 2025

Source: https://www.globalkeysolutions.net/records/483/elite-ivf-fertility-solutions-llc/a4773128-4356-499f-9e88-6989ae2fdc2c

> FDA 483 for Elite IVF & Fertility Solutions LLC on March 28, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elite IVF & Fertility Solutions LLC
- Inspection Date: 2025-03-28
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Elite IVF & Fertility Solutions LLC in Odessa, TX, was inspected regarding its reproductive establishment practices. The inspection revealed two observations primarily concerning incomplete and illegible donor eligibility records for HCT/Ps, specifically oocyte donors. Issues included missing establishment addresses on Summary of Records and various omissions and illegibility in donor eligibility determination forms, some of which were recurring discussion items from previous inspections.

## Related Documents

- [483 - 2023-07-13](https://www.globalkeysolutions.net/records/483/elite-ivf-fertility-solutions-llc/141ea3d9-b98d-4762-9569-a37adbc8df27)

## Related Officers

- [Michelle Paxon](https://www.globalkeysolutions.net/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)

Company: https://www.globalkeysolutions.net/companies/elite-ivf-fertility-solutions-llc/fc636edf-b6de-440e-8f65-3f89c222b32e

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9