# FDA 483 - Stony Brook University Medical Center - February 07, 2023

Source: https://www.globalkeysolutions.net/records/483/stony-brook-university-medical-center/36c6c4ee-219d-422d-9634-707e185cfe44

> FDA 483 for Stony Brook University Medical Center on February 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stony Brook University Medical Center
- Inspection Date: 2023-02-07
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Stony Brook University Medical Center's blood bank revealed significant deficiencies in reporting, record-keeping, and standard operating procedures. The facility failed to submit biological product deviation reports for numerous incidents involving blood product expiration dates, mislabeling, and incorrect patient issuance. Additionally, the inspection found inadequate quality control records for blood warmers and incomplete SOPs for blood collection, storage, and distribution, including donor screening and product visual inspection.

## Related Documents

- [483 - 2019-03-14](https://www.globalkeysolutions.net/records/483/stony-brook-university-medical-center/77df553d-3494-43f1-a4d1-1eb4e7f11b57)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/stony-brook-university-medical-center/111354fe-6c16-4716-84e1-143570d298db

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