FDA 483 - Cooper Institute for Advanced Reproductive Medicine - October 29, 2025

The Cooper Institute for Advanced Reproductive Medicine in Houston, TX, received a Form FDA 483 with 10 observations during an inspection from October 14-29, 2025. The observations primarily concern significant deficiencies in donor eligibility determination, screening, testing, recordkeeping, and the establishment of required procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), with several issues being repeat observations from a previous inspection. These findings indicate a lack of adequate controls to ensure the safety and quality of HCT/Ps.