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

An FDA inspection conducted at Stony Brook Community Medical PC - Island Fertility, a reproductive human tissue establishment, from May 9 to May 28, 2024, identified significant issues in donor screening and product labeling practices. The facility received a Form FDA 483 citing four key observations.

Primary violations included approving donors as eligible despite positive test results for communicable disease agents, specifically Hepatitis B Core Total Antibody. Furthermore, several donors were deemed eligible even with incomplete health screenings for crucial infectious diseases like Syphilis, and neurodegenerative conditions such as CJD. The inspection also revealed that human cells, tissues, and cellular and tissue-based products (HCT/Ps) from ineligible donors or those with incomplete screenings were not appropriately labeled with biohazard warnings or statements about communicable disease risks. Lastly, the facility's standard operating procedures for donor screening lacked clear criteria for evaluating minor health concerns or imminent health risks, potentially compromising thorough eligibility determination.

These observations indicate a need for immediate corrective action to align with federal regulations governing HCT/P safety and ensure the integrity of reproductive tissues.