Company
United StatesNYU Langone Health Institutional Review Board, New York, NY – FDA Inspections
Inspection records and compliance data for NYU Langone Health Institutional Review Board in New York, New York. 4 FDA inspections on record, last inspected April 18, 2023.
Company Profile
This profile covers NYU Langone Health Institutional Review Board based in New York, New York, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 15, 2011. Last inspected April 18, 2023.
Most cited issue areas
- Initial and continuing reviews1 inspection
- Minutes of IRB meetings1 inspection
- Written procedures per 56.108(a) and (b)1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2023 | Not classified | Biologics | 1206663 |
| September 15, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 986827 |
| July 22, 2015 | VAI | Human Drugs · Bioresearch Monitoring | 936460 |
| July 15, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 736685 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
NYU Langone Health Institutional Review Board
FEI Number
2432382
Address
1 Park Ave Fl 6, New York, New York 10016, United States
Country
United States
ID: 8f02a5ab-f35f-4c0c-ab65-42cac52a0774