# FDA 483 - Elite IVF & Fertility Solutions LLC - July 13, 2023

Source: https://www.globalkeysolutions.net/records/483/elite-ivf-fertility-solutions-llc/141ea3d9-b98d-4762-9569-a37adbc8df27

> FDA 483 for Elite IVF & Fertility Solutions LLC on July 13, 2023. 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: 2023-07-13
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Elite IVF & Fertility Solutions LLC in Odessa, TX, received a Form FDA 483 with three observations related to donor screening and record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm was cited for inadequate screening for communicable disease risk factors, failure to determine donor eligibility, and incomplete summaries of communicable disease test results. One observation regarding donor eligibility was removed after discussion with management.

## Related Documents

- [483 - 2025-03-28](https://www.globalkeysolutions.net/records/483/elite-ivf-fertility-solutions-llc/a4773128-4356-499f-9e88-6989ae2fdc2c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab