Company
United StatesUniversity of Massachusetts Chan Medical School IRB, Worcester, MA – FDA Inspections
Inspection records and compliance data for University of Massachusetts Chan Medical School IRB in Worcester, Massachusetts. 4 FDA inspections on record, last inspected November 07, 2023.
Company Profile
This profile covers University of Massachusetts Chan Medical School IRB based in Worcester, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 4, 2009. Last inspected November 7, 2023.
Most cited issue areas
- Method to keep members advised2 inspections
- Minutes of IRB meetings2 inspections
- Initial and continuing reviews1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2023 | Not classified | Human Drugs | 1224376 |
| January 28, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 959087 |
| September 22, 2010 | VAI | Biologics · Bioresearch Monitoring | 682438 |
| December 4, 2009 | VAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 632287 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
University of Massachusetts Chan Medical School IRB
FEI Number
1283421
Address
Ambulatory Care Center, 362 Plantation St Fl 7, Worcester, Massachusetts 01605, United States
Country
United States
ID: d40913f0-9037-47bd-b338-0a3da798d1ef