# FDA 483 - IVF Institute, P.A. - March 04, 2019

Source: https://www.keypedia.com/records/483/ivf-institute-pa/2f95d0c5-9346-46d3-aa56-26d77a4da5f8

> FDA 483 for IVF Institute, P.A. on March 04, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IVF Institute, P.A.
- Inspection Date: 2019-03-04
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of IVF Institute, P.A. in Dallas, TX, revealed significant deficiencies in their HCT/P reproductive services. The firm failed to establish and document adequate procedures for screening and determining donor eligibility. Furthermore, donors were determined eligible without complete screening and testing results, specifically regarding communicable disease agents.

## Related Officers

- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/ivf-institute-pa/e5d1a08d-d1d6-4456-b798-c7e4e7cd65c7

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