# FDA 483 - Stony Brook University Medical Center - March 14, 2019

Source: https://www.globalkeysolutions.net/records/483/stony-brook-university-medical-center/77df553d-3494-43f1-a4d1-1eb4e7f11b57

> FDA 483 for Stony Brook University Medical Center on March 14, 2019. 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: 2019-03-14
- 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 two significant observations. The facility failed to consistently follow its written standard operating procedures for blood collection, specifically regarding skin preparation drying times. Additionally, the inspection found a failure to maintain adequate records for the inspection of returned blood products and for the proper operation and maintenance of blood specimen analyzers.

## Related Documents

- [483 - 2023-02-07](https://www.globalkeysolutions.net/records/483/stony-brook-university-medical-center/36c6c4ee-219d-422d-9634-707e185cfe44)

## 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