FDA 483 - Stony Brook Community Medical PC - Island Fertility - May 28, 2024

Stony Brook Community Medical PC - Island Fertility, a reproductive human tissue establishment, was cited for significant deficiencies in donor eligibility determination, screening, testing, and labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed instances where donors with positive communicable disease tests or incomplete screening were deemed eligible, and HCT/Ps from ineligible donors were not properly labeled with biohazard warnings. Additionally, the firm's standard operating procedures for donor screening lacked clear criteria, potentially allowing ineligible tissues to proceed without proper evaluation.