Fertility Specialists of Texas PLLC.March 29, 2024

FDA 483 - Fertility Specialists of Texas PLLC. - March 29, 2024

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Record Details

An FDA inspection of Fertility Specialists of Texas PLLC in Plano, TX, revealed a critical deficiency in donor screening practices for reproductive tissue. The firm failed to conduct complete physical examinations for several donors to rule out communicable disease agents, yet still deemed them eligible for donation. This oversight could pose potential health risks related to the donated tissues.

Company: Fertility Specialists of Texas PLLC.
Inspection Date: March 29, 2024
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West II
Person: William F. Lagud

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ID · ee1a4b2b-c691-43f2-adce-3606c7b7cc2f