Company
United StatesNorth Shore University Hospital Northwell Health, Manhasset, NY – FDA Inspections
Inspection records and compliance data for North Shore University Hospital Northwell Health in Manhasset, New York. 17 FDA inspections on record, 3 Form 483s, last inspected March 11, 2026.
Company Profile
This profile covers North Shore University Hospital Northwell Health based in Manhasset, New York, United States.
FDA Inspection History
- FDA inspections
- 17
- OAI
- 0
- VAI
- 10
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected March 17, 2009. Last inspected March 11, 2026.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs6 inspections
- Required records5 inspections
- Person performing, test results, interpretation3 inspections
FDA inspections (17)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 11, 2026 | Not classified | Biologics · Blood and Blood Products | 1306816 |
| March 4, 2026 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1307150 |
| June 12, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1241373 |
| April 26, 2023 | VAI | Biologics · Blood and Blood Products | 1203742 |
| July 20, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1174916 |
| March 12, 2020 | NAI | Biologics · Vaccines and Allergenic Products | 1120549 |
| June 6, 2019 | NAI | Biologics · Blood and Blood Products | 1095201 |
| October 16, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1030808 |
| February 8, 2017 | VAI | Biologics · Blood and Blood Products | 1000876 |
| February 23, 2016 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 960774 |
| March 20, 2015 | VAI | Biologics · Blood and Blood Products | 919320 |
| April 7, 2014 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 873470 |
| March 5, 2013 | VAI | Biologics · Blood and Blood Products | 821322 |
| February 3, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 766296 |
| March 23, 2011 | VAI | Biologics · Blood and Blood Products | 715912 |
| June 2, 2009 | VAI | Biologics · Blood and Blood Products | 583467 |
| March 17, 2009 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 570803 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
North Shore University Hospital Northwell Health
FEI Number
2475795
Address
300 Community Dr, Manhasset, New York 11030, United States
Country
United States
ID: 9240ff8d-1ae6-48bf-a7e5-6dd4ec0f267f