# FDA 483 - New York Blood Center Enterprises - December 05, 2025

Source: https://www.keypedia.com/records/483/new-york-blood-center-enterprises/c1db49b5-3e4b-4ede-8ee2-1a5a0a2f9f52

> FDA 483 for New York Blood Center Enterprises on December 05, 2025. 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: 2025-12-05
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: New York Blood Center Enterprises in Melville, NY, a donor center, received a Form 483 following an FDA inspection. Observations included failures to adhere to manufacturer instructions for blood collection systems and to establish, maintain, and follow written standard operating procedures. Additionally, the firm's records were found to be incomplete, lacking proper identification of personnel performing work.

## Related Documents

- [483 - 2018-01-16](https://www.keypedia.com/records/483/new-york-blood-center-enterprises/9d74f045-3a61-432e-97f9-ee9f76608431)
- [483 - 2020-11-09](https://www.keypedia.com/records/483/new-york-blood-center-enterprises/8385b3f9-128a-478b-b6b1-af023182fa15)

## Related Officers

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

Company: https://www.keypedia.com/companies/new-york-blood-center-enterprises/633527fd-9f5f-415c-9008-e8ec548c7b13

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