Texas Fertility CenterJune 21, 2023

FDA 483 - Texas Fertility Center - June 21, 2023

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Record Details

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).

Company: Texas Fertility Center
Inspection Date: June 21, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
People: Maira P. Brading (investigator)
Bobbi Miller

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ID · 76d5ab38-d611-4afe-9810-f9473f39930a