Company
United StatesStony Brook University Medical Center, Stony Brook, NY – FDA Inspections
Inspection records and compliance data for Stony Brook University Medical Center in Stony Brook, New York. 8 FDA inspections on record, 3 Form 483s, last inspected May 27, 2025.
Company Profile
This profile covers Stony Brook University Medical Center based in Stony Brook, New York, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 7
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected May 18, 2010. Last inspected May 27, 2025.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs5 inspections
- Required records4 inspections
- Concurrent documentation2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 27, 2025 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1271190 |
| March 7, 2024 | VAI | Biologics · Blood and Blood Products | 1232197 |
| February 7, 2023 | VAI | Biologics · Blood and Blood Products | 1196757 |
| March 14, 2019 | VAI | Biologics · Blood and Blood Products | 1082588 |
| October 18, 2016 | VAI | Biologics · Blood and Blood Products | 988207 |
| September 30, 2014 | VAI | Biologics · Blood and Blood Products | 897972 |
| July 18, 2012 | VAI | Biologics · Blood and Blood Products | 791259 |
| May 18, 2010 | VAI | Biologics · Blood and Blood Products | 661960 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stony Brook University Medical Center
FEI Number
2477537
Address
101 Nicolls Rd, Stony Brook, New York 11794, United States
Country
United States
ID: 111354fe-6c16-4716-84e1-143570d298db