# FDA 483 - Donor Center Of Nybc - January 12, 2026

Source: https://www.keypedia.com/records/483/donor-center-of-nybc/61397863-6a8e-4068-9bce-39ae8851eb3d

> FDA 483 for Donor Center Of Nybc on January 12, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Donor Center Of Nybc
- Inspection Date: 2026-01-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: New York Blood Center Enterprises in Rockville Centre, NY, was inspected and received a Form 483 with four observations. The inspection revealed issues with adherence to manufacturer instructions for blood collection, inadequate record-keeping for quality control and investigations, and failures to follow and make available standard operating procedures for blood and blood component collection. These findings indicate deficiencies in operational control and documentation practices at the donor center.

## Related Documents

- [483 - 2022-08-03](https://www.keypedia.com/records/483/donor-center-of-nybc/94806c26-e9df-4986-94ea-0bee033a07a6)

## Related Officers

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

Company: https://www.keypedia.com/companies/donor-center-of-nybc/cd3eaba2-84f4-4697-b01b-413cda655faf

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