Company
United StatesNIH Clinical Center, Bethesda, MD – FDA Inspections
Inspection records and compliance data for NIH Clinical Center in Bethesda, Maryland. 8 FDA inspections on record, last inspected January 21, 2025.
Company Profile
This profile covers NIH Clinical Center based in Bethesda, Maryland, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 21, 2009. Last inspected January 21, 2025.
Most cited issue areas
- Biological product deviation report1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Notification w/in 8 weeks1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 21, 2025 | Not classified | Biologics | 1259572 |
| December 1, 2021 | NAI | Biologics · Vaccines and Allergenic Products | 1160826 |
| August 31, 2017 | NAI | Biologics · Blood and Blood Products | 1040752 |
| August 15, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 988673 |
| February 11, 2015 | VAI | Biologics · Blood and Blood Products | 914710 |
| April 23, 2013 | VAI | Biologics · Blood and Blood Products | 838653 |
| March 30, 2011 | NAI | Biologics · Blood and Blood Products | 717090 |
| August 21, 2009 | VAI | Biologics · Blood and Blood Products | 607287 |
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
NIH Clinical Center
FEI Number
1174694
Address
10 Center Dr, Room 3N223 (MSC 1184), Bethesda, Maryland 20892, United States
Country
United States
ID: e0d8654b-1cc5-4b1d-9783-6b75cf0b20e2