FDA 483 - North Hudson IVF Center for Fertility & Gynecology P.C. - July 02, 2024
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North Hudson IVF Center for Fertility & Gynecology, P.C. in Englewood Cliffs, NJ, a human reproductive tissue establishment, was cited for significant deficiencies in its donor screening and record-keeping practices. The inspection revealed inadequate screening for communicable disease risk factors in oocyte donors and incomplete summaries of communicable disease test results for HCT/Ps. Furthermore, the firm lacked established and maintained procedures for donor testing, screening, and eligibility determination.
- Inspection Date
- July 2, 2024
- Product Type
- Biologics
- Person
ID · 16656381-d54a-4c49-9e58-b2b0e6a4d9c9