Andra Andrology and Embryology LLCSeptember 12, 2025

FDA 483 - Andra Andrology and Embryology LLC - September 12, 2025

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Andra Andrology and Embryology LLC in Austin, TX, received a Form 483 following an inspection from September 11-12, 2025. The inspection revealed a significant deficiency in donor screening practices. Specifically, the firm failed to screen oocyte and semen donors by reviewing relevant medical records for various communicable disease risk factors.

Company: Andra Andrology and Embryology LLC
Inspection Date: September 12, 2025
Product Type: Other
Office: Division of Human and Animal Food Operations - West III
People: Laurissa S. Flowers
Michelle Paxon

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ID · f8bdf9c9-0bb7-46da-a04f-d095a0af585c