# FDA 483 - New York Cryo - January 23, 2019

Source: https://www.keypedia.com/records/483/new-york-cryo/236b776f-4af6-47a1-84a4-06a05cb781b9

> FDA 483 for New York Cryo on January 23, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Cryo
- Inspection Date: 2019-01-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/new-york-cryo/7fb7224b-266e-4404-8c5b-8999319c5a95

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961