Company
United StatesStaten Island University Hospital Northwell Health, Staten Island, NY – FDA Inspections
Inspection records and compliance data for Staten Island University Hospital Northwell Health in Staten Island, New York. 6 FDA inspections on record, last inspected January 16, 2020.
Company Profile
This profile covers Staten Island University Hospital Northwell Health based in Staten Island, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 4, 2010. Last inspected January 16, 2020.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Legibility and indelibility2 inspections
- Donor suitability procedures not followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2020 | NAI | Biologics · Blood and Blood Products | 1116042 |
| October 4, 2017 | NAI | Biologics · Blood and Blood Products | 1034697 |
| February 5, 2015 | VAI | Biologics · Blood and Blood Products | 911772 |
| November 19, 2012 | NAI | Biologics · Blood and Blood Products | 807499 |
| December 14, 2011 | VAI | Biologics · Blood and Blood Products | 756348 |
| March 4, 2010 | VAI | Biologics · Blood and Blood Products | 649252 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Staten Island University Hospital Northwell Health
FEI Number
2473418
Address
475 Seaview Ave, Staten Island, New York 10305, United States
Country
United States
ID: 8daf3b95-6104-4449-93be-a7ecb7b88e0f