New York Cryo – FDA EIR, Apr 25, 2022

An FDA inspection of New York Cryo, a reproductive tissue establishment in Great Neck, NY, was conducted from April 13-25, 2022. This inspection, conducted under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), identified several significant compliance issues. The main violations, detailed in a Form FDA 483, included a failure to properly assess donor eligibility. Specifically, one directed donor with identified risk factors for communicable disease agents was still deemed eligible without clear, documented procedures for such situations. Furthermore, donor eligibility determinations were frequently made prematurely, before all required communicable disease testing results were reported, leading to potential risks. A critical, repeated observation concerned the absence of comprehensive and updated standard operating procedures (SOPs) for donor screening, testing, and eligibility determination. Existing procedures were found to be incomplete, lacking specific criteria for certain screening questions and failing to define actions based on test results, such as for West Nile Virus. Additionally, the summary records for HCT/Ps distributed did not consistently include the name and address of the establishment responsible for the donor eligibility determination. New York Cryo's Medical Director, Dr. Gilbert, acknowledged these deficiencies and committed to immediate corrective actions. These include revising and updating all incomplete SOPs to align with regulatory requirements, ensuring donor eligibility is solely based on complete screening and testing results, and accurately incorporating the firm's identifying information on all donor summary records. Dr. Gilbert also agreed to quarantine any donations where eligibility could not be fully confirmed due to incomplete testing. A written response outlining these actions is expected within 15 business days.