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483
•Southwest Fertility Center•March 16, 2021

Southwest Fertility Center – FDA 483, Mar 16, 2021

Record Details

An FDA inspection of Southwest Fertility Center in Phoenix, AZ, identified a critical failure in donor screening protocols. The firm did not test donors of multiple oocyte and semen donations for West Nile Virus, a relevant communicable disease agent, before deeming them eligible. This lapse raises concerns regarding the safety and compliance of their reproductive tissue operations.

Company
Southwest Fertility Center
Inspection date
March 16, 2021
Product type
biologics
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Garrad R. Poole
View Company Profile

ID · 2716aed2-5114-4aaa-b5d8-46aee7a24f11

Other documents for Southwest Fertility Center
  • 483 - 2026-04-14April 14, 2026

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