Company
United StatesHallmark Health Comprehensive Breast Center, Stoneham, MA – FDA Inspections
Inspection records and compliance data for Hallmark Health Comprehensive Breast Center in Stoneham, MA. 6 FDA inspections on record, last inspected October 14, 2025.
Company Profile
This profile covers Hallmark Health Comprehensive Breast Center based in Stoneham, MA, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected March 10, 2017. Last inspected October 14, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 14, 2025 | Not classified | Medical Devices & Rad Health | 1288544 |
| November 14, 2024 | Not classified | Medical Devices & Rad Health | 1255187 |
| November 20, 2023 | Not classified | Medical Devices & Rad Health | 1223996 |
| March 1, 2019 | Not classified | Medical Devices & Rad Health | 1096033 |
| February 23, 2018 | Not classified | Medical Devices & Rad Health | 1043168 |
| March 10, 2017 | Not classified | Medical Devices & Rad Health | 1014869 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
UMASS Memorial Hahnemann Radiology - Hahnemann Campus
Atrius Health, Inc - Imaging Dept
Mount Auburn Radiology at Concord Ave.
MGH West Women's Imaging Center
Southcoast Hospitals Group Radiology Services
Sagoff Breast Imaging and Diagnostic Centre
New England Medical Center Hospitals
Tollgate Radiology II, LLC
Compass Medical, P.C.
Newton Wellesley Hospital Imaging Services
Company Information
Name
Hallmark Health Comprehensive Breast Center
FEI Number
3009493601
Address
41 Montvale Ave, Stoneham, MA 02180-2445, United States
Country
United States
ID: 08d9d126-6312-4bfb-bfe6-96d3b446a136