FDA 483 - Foulk & Whitten Nevada Center For Reproductive Medicine - March 28, 2019

An FDA inspection of Nevada Center For Reproductive Medicine, a human reproductive tissue establishment in Reno, NV, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen donors for various communicable disease agents and lacked established procedures for determining donor eligibility and documenting ineligibility reasons for HCT/Ps. These findings indicate serious concerns regarding the safety and quality of donor tissues.