Lin, James P MD Inc – FDA 483, Mar 12, 2025

Lin, James P MD Inc. d.b.a. Reproductive Fertility Center in Irvine, CA, was cited for multiple deficiencies related to donor eligibility determination, HCT/P labeling, and communicable disease testing. Observations included failures to properly screen and test donors, inadequate labeling of HCT/Ps from ineligible donors or those not requiring eligibility determination, and untimely collection of donor specimens for disease testing. These issues indicate significant concerns regarding the safety and proper handling of reproductive human tissues.