New Infertility Center of St LouisApril 22, 2026

FDA 483 - New Infertility Center of St Louis - April 22, 2026

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Record Details

An FDA inspection of New Infertility Center of St Louis in Chesterfield, MO, revealed critical deficiencies in their Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) program. The firm failed to adequately screen oocyte donors for communicable disease risks, improperly determined donor eligibility despite incomplete screening, and maintained inadequate procedures for ensuring compliance with donor eligibility requirements. These issues indicate a significant risk regarding the safety and suitability of donated oocytes.

Company: New Infertility Center of St Louis
Inspection Date: April 22, 2026
Product Type: Biologics
Office: Kansas City District Office
Person: Lesley Mae P. Lutao

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ID · 11ecdbb7-f77d-4847-bb2d-9dc3b38f848f