FDA 483 - New York Cryo - January 23, 2019

An FDA inspection of New York Cryo in Great Neck, NY, revealed two significant observations related to the handling of reproductive human tissue. The firm failed to collect donor specimens for communicable disease testing at the appropriate time and lacked adequately defined and documented procedures for screening and determining donor eligibility, particularly concerning Zika Virus risk. These deficiencies indicate potential risks to HCT/P safety and compliance with regulatory requirements.