FDA 483 - Manhattan Fertility Services LLC - April 06, 2023

Manhattan Fertility Services LLC underwent an FDA inspection from March 15 to April 6, 2023, regarding its operations as a Human Reproductive Tissue Establishment. The inspection identified two significant observations concerning donor screening and tissue labeling practices, indicating potential non-compliance with regulatory expectations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

The first observation highlighted a failure to adequately screen directed semen donors for communicable disease risk factors, specifically Zika Virus exposure or travel to affected areas. The firm's donor risk assessment questionnaire did not include these critical screening elements for donors between May 2020 and July 2022, potentially failing to identify donors with transmissible disease risks.

The second major issue involved the insufficient labeling of reproductive tissues from ineligible donors. In two documented cases, directed semen donors tested positive for Hepatitis B core total antibody, rendering them ineligible. However, the resulting reproductive tissues were not prominently labeled with the required warning statement, "WARNING: Reactive test results for (name of disease agent or disease)," which is essential for informing potential recipients of associated risks.

These findings necessitate that Manhattan Fertility Services LLC implement prompt and effective corrective actions to ensure comprehensive donor screening for communicable diseases and accurate, prominent labeling of HCT/Ps derived from ineligible donors, thereby aligning with FDA regulations and enhancing public health safety.