# FDA 483 - NYU Langone Reproductive Specialists of New York - September 25, 2020

Source: https://www.globalkeysolutions.net/records/483/nyu-langone-reproductive-specialists-of-new-york/9ef97289-8edf-4b3c-a772-5bc49d11ba36

> FDA 483 for NYU Langone Reproductive Specialists of New York on September 25, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NYU Langone Reproductive Specialists of New York
- Inspection Date: 2020-09-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: NYU Langone Reproductive Specialists of New York in Mineola, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed deficiencies in determining HCT/P donor eligibility, including premature eligibility determinations before communicable disease test results were finalized and an inadequate screening questionnaire for Zika virus risk factors. Additionally, donor specimens for communicable disease testing, specifically for West Nile Virus, were not collected within the required timeframes.

## Related Documents

- [483 - 2021-09-30](https://www.globalkeysolutions.net/records/483/nyu-langone-reproductive-specialists-of-new-york/2f897fd9-5785-4e4e-9b94-1ed12330a3b7)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/nyu-langone-reproductive-specialists-of-new-york/52eb9f0c-c77b-402f-814f-99231ae84dd1

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