# FDA 483 - New York Blood Center Enterprises - April 03, 2026

Source: https://www.keypedia.com/records/483/new-york-blood-center-enterprises/5c23488f-946d-4bc2-81bf-230ed61f964f

> FDA 483 for New York Blood Center Enterprises on April 03, 2026. 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: 2026-04-03
- Product Type: biologics
- Office Name: New York District Office
- Summary: New York Blood Center Enterprises in Rye, NY, received an FDA Form 483 with eight observations related to significant deficiencies in their blood and blood component manufacturing processes. Key issues include inadequate standard operating procedures, poor record-keeping, failure to report biological product deviations, and insufficient personnel training. These findings indicate a lack of control over critical aspects of blood product quality, safety, and traceability.

## Related Documents

- [483 - 2017-09-29](https://www.keypedia.com/records/483/new-york-blood-center-enterprises/89e4ed87-8aee-4226-bc00-c4c265fec5a4)
- [483 - Unknown Date](https://www.keypedia.com/records/483/new-york-blood-center-enterprises/eed1c575-459e-4f2d-b827-52aeb89623d1)
- [483 - 2020-02-11](https://www.keypedia.com/records/483/new-york-blood-center-enterprises/3e5035ef-b0ef-43ea-b48b-39547a2005ad)

## Related Officers

- [Jennifer L. Diaz](https://www.keypedia.com/people/jennifer-l-diaz/02f69ae1-5daf-45bc-8047-84e302e5c68d)
- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)
- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d