Company
United StatesMagellan Diagnostics, Inc., North Billerica, MA – FDA Inspections
Inspection records and compliance data for Magellan Diagnostics, Inc. in North Billerica, Massachusetts. 7 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected August 26, 2025.
Company Profile
This profile covers Magellan Diagnostics, Inc. based in North Billerica, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected March 9, 2011. Last inspected August 26, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate3 inspections
- Individual Report of Malfunction3 inspections
- Lack of or inadequate procedures3 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 26, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1280392 |
| June 22, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1144696 |
| October 21, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1107302 |
| June 29, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1016218 |
| June 25, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 884803 |
| February 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 765692 |
| March 9, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 716551 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Criticare Technologies, Inc.
Greiner Bio-One North America, Inc.
Compass Health Brands (Corporate Office)
Microlight Corporation of America
Curonix LLC
Hunter Holmes McGuire Veterans Affairs Medical Center Mammography
MHC Medical Products LLC
Cogmedix, Inc.
High Technology, Inc.
Terumo Cardiovascular Systems Corp
Company Information
Name
Magellan Diagnostics, Inc.
FEI Number
1218996
Address
101 Billerica Ave Bldg 4, North Billerica, Massachusetts 01862, United States
Country
United States
ID: cb8c497d-025f-4929-a799-724a015d3677