# FDA 483 - New York Blood Center Enterprises - July 06, 2023

Source: https://www.keypedia.com/records/483/new-york-blood-center-enterprises/254d5867-290f-4b3f-b285-7a63366dcb3a

> FDA 483 for New York Blood Center Enterprises on July 06, 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: 2023-07-06
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: New York Blood Center Enterprises in New York, NY, was inspected and cited for multiple deficiencies related to blood and blood component collection, record-keeping, and deviation reporting. Observations included failures to follow standard operating procedures, maintain adequate records, adhere to manufacturer instructions, and report biological product deviations in a timely manner. These issues indicate significant concerns with quality control and traceability in their blood bank and donor center operations.

## 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/694e089d-d144-4b01-8785-e04f23f49d56

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