FDA 483 - Southwest Fertility Center - April 14, 2026
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An FDA inspection of Southwest Fertility Center in Phoenix, AZ, identified multiple deficiencies related to donor eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to ensure donors were properly tested and screened for communicable diseases, maintained incomplete and inaccurate donor records, and lacked proper documentation of eligibility determinations. These issues indicate significant non-compliance in ensuring the safety and suitability of HCT/P donors.
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ID · f24f07b3-16f8-4b7a-8ac8-f25aacf04a82