483
Foulk Nevada Fertility Center, PCFoulk Nevada Fertility Center, PC – FDA 483, Feb 8, 2019
Record Details
IntegraMed Medical - King, PLLC in Las Vegas, NV, was cited for significant deficiencies in its human tissue establishment operations. The inspection revealed failures in donor screening for communicable diseases, inadequate labeling of HCT/Ps, and poorly defined standard operating procedures for donor eligibility. Additionally, donor eligibility records were found to be inaccurate regarding who performed the final determinations.
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ID · 61f160c6-2622-4505-ab67-6ae4395440d6
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