# FDA 483 - New York Blood Center Enterprises - September 29, 2017

Source: https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/89e4ed87-8aee-4226-bc00-c4c265fec5a4

> FDA 483 for New York Blood Center Enterprises on September 29, 2017. 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: 2017-09-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York Blood Center, Inc. in Long Island City revealed significant deficiencies in their blood bank operations. Observations included failures to establish and follow adequate standard operating procedures for blood product irradiation and donor physical examinations, as well as issues with maintaining proper temperatures during Red Blood Cell shipments. Additionally, the firm lacked sufficient documentation for the validation of its electronic health history questionnaire and exhibited discrepancies in concurrent record-keeping for blood component processing.

## Related Documents

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## Related Officers

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

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