FDA 483 - RMA Long Island IVF - February 09, 2024

An FDA inspection of RMA Long Island IVF in Melville, NY, a reproductive human tissue establishment, identified significant issues related to donor eligibility determination and record-keeping. The firm failed to properly determine and document HCT/P donor eligibility, particularly for directed semen donors whose partners tested positive for communicable diseases. Additionally, the facility lacked established procedures for screening and determining donor eligibility and maintained inaccurate, illegible, and altered donor eligibility records.