483
Aspire Fertility Institute DallasAspire Fertility Institute Dallas – FDA 483, Jul 12, 2023
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.
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ID · e92fedb9-2099-4e08-a5b4-c4d1ade25229
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