# FDA 483 - New York Blood Center Inc - December 12, 2025

Source: https://www.keypedia.com/records/483/new-york-blood-center-inc/4b525b63-1ad2-44bd-9711-96dfc56e3546

> FDA 483 for New York Blood Center Inc on December 12, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Blood Center Inc
- Inspection Date: 2025-12-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York Blood Center Enterprises' donor center in Massapequa, NY, revealed significant deficiencies in adherence to manufacturer instructions for blood collection supplies and reagents. The inspection also identified failures in establishing, maintaining, and following written standard operating procedures for blood collection, as well as inadequate quality control and general record-keeping practices. These issues indicate a need for improved procedural compliance and documentation to ensure the safety and quality of collected blood and blood components.

## Related Documents

- [483 - 2018-05-01](https://www.keypedia.com/records/483/new-york-blood-center-inc/d0dc4e9a-23cc-4a9c-baef-c8ec47f982fe)
- [483 - 2021-02-24](https://www.keypedia.com/records/483/new-york-blood-center-inc/46a7dfcb-fdde-4e76-8556-ca7167ebde3a)

## 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-inc/ffed078a-99a5-4934-961a-8262fee09c76

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