FDA 483 - James P. Lin, M.D., Inc. - March 05, 2020

Lin Fertility Network, Inc. in Corona, CA, was inspected regarding its human reproductive tissue operations. The inspection revealed significant deficiencies in donor screening and labeling practices for human cells, tissues, and cellular and tissue-based products (HCT/Ps). These issues include inadequate labeling of HCT/Ps from ineligible donors, insufficient screening for communicable diseases like Zika Virus, and incomplete documentation of donor ineligibility reasons.