FDA 483 - Cooper Institute for Advanced Reproductive Medicine - November 16, 2023

The Cooper Institute for Advanced Reproductive Medicine in Houston, TX, received a Form FDA 483 with 11 observations following an inspection from November 13-16, 2023. The inspection revealed significant deficiencies in donor eligibility determination, screening, testing, labeling, record-keeping, and the establishment of required procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Several observations, including failures in donor screening, establishing procedures, and indelible records, were noted as repeat issues.