# FDA 483 - North Shore University Hospital Northwell Health - April 26, 2023

Source: https://www.globalkeysolutions.net/records/483/north-shore-university-hospital-northwell-health/a4c4608e-9414-43be-88b1-1d124d0cef28

> FDA 483 for North Shore University Hospital Northwell Health on April 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North Shore University Hospital Northwell Health
- Inspection Date: 2023-04-26
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: North Shore University Hospital Northwell Health, a blood bank in Manhasset, NY, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed failures in submitting biological deviation reports, not consistently following written standard operating procedures for blood product handling, and inadequate maintenance of quality control and general records for analyzer operating conditions. These issues indicate deficiencies in quality system controls and record-keeping practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/north-shore-university-hospital-northwell-health/9240ff8d-1ae6-48bf-a7e5-6dd4ec0f267f

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