FDA 483 - Cooper Institute for Advanced Reproductive Medicine - July 19, 2021

The Cooper Institute in Houston, TX, received a Form FDA 483 citing significant deficiencies in its human reproductive tissue establishment operations. Observations included failures in screening and testing donors for communicable disease risks like Zika and West Nile viruses, and a lack of proper documentation for physical examinations and donor eligibility. The firm also failed to establish written procedures for donor eligibility and to label non-compliant HCT/Ps with required warning statements.