# FDA 483 - New York Blood Center Enterprises - February 11, 2020

Source: https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/3e5035ef-b0ef-43ea-b48b-39547a2005ad

> FDA 483 for New York Blood Center Enterprises on February 11, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Blood Center Enterprises
- Inspection Date: 2020-02-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: New York Blood Center, Inc. in Long Island City, NY, was inspected for human cord blood processing and received a Form 483 with four observations. The inspection revealed significant issues with laboratory controls, including a lack of sound specifications and failure to follow established procedures, leading to miscalculated results for cord blood units. Additionally, the firm failed to thoroughly investigate discrepancies and had inadequate donor screening for communicable disease risk factors like Zika virus.

## Related Documents

- [483 - 2017-09-29](https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/89e4ed87-8aee-4226-bc00-c4c265fec5a4)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/eed1c575-459e-4f2d-b827-52aeb89623d1)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)
- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/new-york-blood-center-enterprises/29bd2008-0b6c-4674-90f5-96ad1caea4db

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