FDA 483 - Cooper Institute for Advanced Reproductive Medicine - December 09, 2022

The Cooper Institute for Advanced Reproductive Medicine was cited for multiple deficiencies related to human reproductive tissue establishment operations. The inspection revealed failures in testing oocyte donors for communicable diseases like West Nile Virus, incomplete donor screening questionnaires, and inadequate record retention for HCT/Ps. Additionally, the firm lacked standard operating procedures for handling CMV-positive donors and for overall donor testing, screening, and eligibility determination.