FDA 483 - Stony Brook Community Medical PC - Island Fertility - July 13, 2022

An FDA inspection of Stony Brook Community Medical PC - Island Fertility in Commack, NY, revealed significant issues with their Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) program. The firm failed to properly determine donor eligibility based on complete screening and testing results, and their standard operating procedures for donor screening were inadequate. Additionally, donor eligibility records were found to be inaccurate and lacked proper documentation of changes.