483
Community Fertility Specialty CareCommunity Fertility Specialty Care – FDA 483, Jan 11, 2024
Record Details
An FDA inspection of Community Fertility Specialty Care in Indianapolis, IN, revealed significant deficiencies in donor eligibility determination and communicable disease testing for oocyte donors. The firm failed to test donors for relevant communicable diseases like West Nile Virus and Hepatitis B, and did not maintain proper documentation for donor eligibility. Additionally, the facility's procedures were inadequate to ensure compliance with required donor screening tests.
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ID · ad04e738-2cad-4753-a080-fd81a3a9ee90
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