FDA 483 - North Carolina Center for Reproductive Medicine Inc (NCCRM) - March 16, 2020
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The FDA inspected North Carolina Center for Reproductive Medicine Inc (NCCRM) in Cary, NC, a reproductive HCT/P facility. The inspection revealed deficiencies in donor screening and testing procedures for cryopreserved embryos, particularly concerning documentation for donors whose embryos were later used with gestational carriers. Additionally, the facility failed to adequately screen anonymous oocyte donors for communicable disease risk factors, including HIV, Vaccinia, and West Nile Virus.
- Inspection Date
- March 16, 2020
- Product Type
- Biologics
- Office
- Atlanta District Office
- Person
ID · f09dccd5-0b67-43c6-a312-ecafc2ec57f4