New York Fertility Institute – FDA EIR, Sep 8, 2016

A routine comprehensive inspection of the New York Fertility Institute, a reproductive tissue facility, was conducted by the FDA from September 6 to September 8, 2016. The inspection aimed to ensure compliance with regulations pertaining to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Areas reviewed included donor eligibility, infectious disease testing, and Standard Operating Procedure (SOP) efficacy, among others. Notably, the inspection concluded without the issuance of a Form FDA 483, indicating a generally high level of adherence to regulatory standards.

However, during the close-out meeting, verbal observations were discussed with management. The primary issue identified was the need to update existing SOPs related to donor eligibility to accurately reflect the current forms utilized by the facility. An example cited was an SOP that still referenced an obsolete medical and psychological history interview form, despite newer forms being in active use. Management promptly acknowledged this observation and committed to implementing the necessary corrections and updates to their SOPs to align them with current operational practices.