FDA 483 - Foulk Nevada Fertility Center, PC - February 08, 2019

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.