483
North Carolina Center for Reproductive Medicine Inc (NCCRM)North Carolina Center for Reproductive Medicine Inc (NCCRM) – FDA 483, Jan 26, 2023
Record Details
An FDA inspection of North Carolina Center for Reproductive Medicine Inc (NCCRM) in Cary, NC, revealed significant deficiencies in determining HCT/P donor eligibility. The firm accepted multiple gamete donors despite incomplete health history screenings, positive risk factors, or lack of documentation regarding treatment or ineligibility. These practices raise concerns about the safety and suitability of the HCT/Ps processed by the facility.
- Inspection date
- January 26, 2023
- Product type
- biologics
- Office
- Atlanta District Office
- Person
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ID · 412e68db-5508-4b10-a3b1-889e13efe19a
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