Company
United StatesBrigham And Women's Hospital, Boston, MA – FDA Inspections
Inspection records and compliance data for Brigham And Women's Hospital in Boston, Massachusetts. 10 FDA inspections on record, 1 Form 483, last inspected June 12, 2024.
Company Profile
This profile covers Brigham And Women's Hospital based in Boston, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 1
- NAI
- 9
- Form 483s
- 1
- Warning letters
- 0
First inspected November 19, 2009. Last inspected June 12, 2024.
Most cited issue areas
- Infection with communicable disease agents1 inspection
- Risk factors, clinical evidence1 inspection
- Testing, screening, donor eligibility procedures1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 12, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1244354 |
| July 21, 2021 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1148014 |
| September 26, 2019 | NAI | Biologics · Blood and Blood Products | 1103194 |
| June 23, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1019087 |
| March 31, 2015 | NAI | Biologics · Blood and Blood Products | 926547 |
| March 6, 2014 | NAI | Biologics · Blood and Blood Products | 868904 |
| August 13, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 844112 |
| August 4, 2011 | NAI | Biologics · Blood and Blood Products | 737804 |
| May 5, 2010 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 660774 |
| November 19, 2009 | NAI | Biologics · Blood and Blood Products | 630943 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Brigham And Women's Hospital
FEI Number
1270016
Address
75 Francis St, Boston, Massachusetts 02115, United States
Country
United States
ID: bd1bc676-ff7b-48b7-b9a2-3db7aaf9732d