Fertility Center of DallasAugust 25, 2021

FDA 483 - Fertility Center of Dallas - August 25, 2021

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The FDA issued a Form 483 to Fertility Center of Dallas following an inspection of their reproductive HCT/P establishment. The inspection revealed a failure to establish and maintain adequate procedures for testing and screening HCT/P donors. Specifically, the firm lacked instructions for reviewing Zika Virus screening questions and failed to list the West Nile Virus NAT in their procedures.

Company: Fertility Center of Dallas
Inspection Date: August 25, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: Decarlos A. Gomez

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ID · 6a5e0734-64ae-4b9e-9587-30abc595ed83