FDA 483 - Nest Cryobank LLC - September 17, 2024

Nest Cryobank LLC, a human reproductive tissue establishment located in San Francisco, California, underwent an FDA inspection from September 16-17, 2024. During this inspection, the FDA issued a Form 483, detailing a significant observation regarding donor eligibility screening practices. The primary issue identified was the failure to determine donors ineligible who presented risk factors or clinical evidence of communicable disease agents. Specifically, an anonymous oocyte donor was deemed eligible despite her health history interview indicating recent travel to an area with an active Zika virus outbreak within the last six months. Following this eligibility determination, oocytes from this donor were retrieved and subsequently used to create multiple embryos for a patient. These embryos have been cryopreserved on-site and are currently awaiting implantation, potentially posing a risk of Zika virus transmission. This observation highlights a lapse in adherence to regulatory requirements for screening human reproductive tissue donors to prevent the transmission of communicable diseases. As a result of this FDA 483 observation, Nest Cryobank LLC is expected to address the identified deficiency by reviewing their donor screening protocols and implementing appropriate corrective and preventive actions to ensure compliance and patient safety.