# FDA 483 - Texas Fertility Center - June 21, 2023

Source: https://www.globalkeysolutions.net/records/483/texas-fertility-center/76d5ab38-d611-4afe-9810-f9473f39930a

> FDA 483 for Texas Fertility Center on June 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texas Fertility Center
- Inspection Date: 2023-06-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Texas Fertility Center in New Braunfels, TX, revealed a critical deficiency in their donor screening process. The facility failed to adequately screen donors for communicable disease risk factors, utilizing incomplete medical history questionnaires. This lapse could potentially compromise the safety of human cells, tissues, and cellular and tissue-based products (HCT/P).

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)
- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)

Company: https://www.globalkeysolutions.net/companies/texas-fertility-center/3d635c31-8539-4b4e-81ce-efc64da90170

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