Aspire Fertility Institute DallasJuly 12, 2023

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

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Record Details

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.

Company: Aspire Fertility Institute Dallas
Inspection Date: July 12, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: Bobbi Miller

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ID · e92fedb9-2099-4e08-a5b4-c4d1ade25229