483
Kofinas Fertility GroupFDA 483 - Kofinas Fertility Group - July 25, 2023
Record Details
The Kofinas Fertility Group in New York, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in determining and documenting HCT/P donor eligibility, including issues with record accuracy, legibility, and inadequate screening for infectious disease risks like Zika Virus. These findings indicate a failure to ensure the safety and suitability of donated oocytes.
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ID · f93f6c79-4dfe-433d-a3d7-50fe72da9871
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