# FDA 483 - New York Blood Center Enterprises - November 09, 2020

Source: https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/8385b3f9-128a-478b-b6b1-af023182fa15

> FDA 483 for New York Blood Center Enterprises on November 09, 2020. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: New York Blood Center Enterprises
- Inspection Date: 2020-11-09
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York Blood Center Enterprises in Melville, NY, a donor center, revealed deficiencies in their written standard operating procedures for blood and blood component collection. Specifically, the firm lacked a procedure for disconnecting donors during paused plasma collection and failed to follow proper technique for blood pressure checks. These issues indicate a failure to establish and follow critical procedures for allogeneic transfusion.

## Related Documents

- [483 - 2018-01-16](https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/9d74f045-3a61-432e-97f9-ee9f76608431)

## 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/633527fd-9f5f-415c-9008-e8ec548c7b13

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