# FDA 483 - New York Blood Center Enterprises - December 22, 2023

Source: https://www.keypedia.com/records/483/new-york-blood-center-enterprises/28217af4-b0f5-4f6c-8ba3-6e1b20a287ad

> FDA 483 for New York Blood Center Enterprises on December 22, 2023. 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: 2023-12-22
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: New York Blood Center Enterprises, a donor center in Ronkonkoma, NY, was cited for significant deviations during an FDA inspection. Observations included failures to consistently follow written standard operating procedures for blood collection and donor selection, as well as not adhering to manufacturer instructions for supplies. Additionally, the firm's records failed to adequately identify personnel performing work, often listing "Unknown Operator."

## 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/9f2a4f56-c3b2-4ee4-95a2-a77827302570

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