483
Northern California Fertility Medical CenterNorthern California Fertility Medical Center – FDA 483, Aug 19, 2025
Record Details
An FDA inspection of NCFMC, a Medical Corporation, a human reproductive tissue establishment in Sacramento, CA, revealed significant deficiencies in donor eligibility determinations and communicable disease testing. The firm failed to deem ineligible donors with risk factors and did not follow manufacturer instructions for testing. Additionally, the inspection found inadequate and inconsistent written procedures for donor eligibility, risk factor management, and record review.
- Inspection date
- August 19, 2025
- Product type
- biologics
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ID · ed391a9d-1158-47df-a1f3-02aeedbc74e7
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