# FDA 483 - Aspire Fertility Institute Dallas - July 12, 2023

Source: https://www.keypedia.com/records/483/aspire-fertility-institute-dallas/e92fedb9-2099-4e08-a5b4-c4d1ade25229

> FDA 483 for Aspire Fertility Institute Dallas on July 12, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aspire Fertility Institute Dallas
- Inspection Date: 2023-07-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Aspire Fertility Institute Dallas, a reproductive HCT/P establishment in Addison, TX, revealed two significant observations. The facility failed to ensure that summaries of records for HCT/Ps included statements confirming communicable disease testing was performed by CLIA-certified laboratories. Additionally, donor eligibility screening documents were found to be incomplete, lacking critical information for assessing donor risk.

## Related Officers

- [Bobbi Miller](https://www.keypedia.com/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)

Company: https://www.keypedia.com/companies/aspire-fertility-institute-dallas/6cdc8d6b-1dcf-4e4d-b543-4a4f66be1c65

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