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. 6 FDA inspections on record (2 OAI), 2 Form 483s, last inspected June 22, 2026.
Company Profile
This profile covers Brigham and Women's Hospital based in Boston, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 15, 2014. Last inspected June 22, 2026.
Most cited issue areas
- Orderly handling, prevention of mix-ups, prevention of contamination3 inspections
- Determination need for investigation2 inspections
- Written QA procedures established, followed2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 22, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1323146 |
| April 11, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1203279 |
| September 16, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1152063 |
| August 22, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1100702 |
| December 10, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 953620 |
| August 15, 2014 | VAI | Human Drugs · Drug Quality Assurance | 891621 |
FDA documents
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Company Information
Name
Brigham and Women's Hospital
FEI Number
3012030543
Address
75 Francis St, Boston, Massachusetts 02115, United States
Country
United States
ID: b4f9a511-289b-4ec1-9b75-a783b3763c96