FDA EIR - M FATEH & K SULTAN M D S P C - April 25, 2019

The FDA conducted a comprehensive inspection of M FATEH & K SULTAN M D S P C, operating as the New York Fertility Institute, from April 17-18 and April 24-25, 2019. This human reproductive tissue establishment, specializing in assisted reproductive technologies, was evaluated under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps). The firm performs various services, including the recovery, screening, testing, processing, labeling, storage, and distribution of HCT/Ps from anonymous/directed oocyte donors and directed sperm donors, as well as handling oocytes/semen from client-depositors. During the inspection, one procedural discrepancy was identified: while the firm performed testing for HBV NAT and WNV NAT, these requirements were not documented in their written procedures for anonymous and directed oocyte and semen donors. Management promptly corrected this omission in the presence of the inspector. Additionally, it was discussed that the firm should update its FDA registration to reflect its legal name, M FATEH & K SULTAN M D S P C, rather than its dba name. Notably, no formal FDA 483 Inspectional Observations Form was issued at the conclusion of this inspection, indicating that the identified issues did not warrant a formal notice. Previous inspections had resulted in more significant findings, including an Order to Cease Manufacturing in 2012, but the firm had resumed normal operations in 2014, and similar deficiencies were not observed during the current review.