Company
United StatesMedtronic Navigation, Inc.-Boxborough, Boxborough, MA – FDA Inspections
Inspection records and compliance data for Medtronic Navigation, Inc.-Boxborough in Boxborough, Massachusetts. 6 FDA inspections on record, 1 Form 483, last inspected June 11, 2024.
Company Profile
This profile covers Medtronic Navigation, Inc.-Boxborough based in Boxborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected June 15, 2010. Last inspected June 11, 2024.
Most cited issue areas
- Individual Report of Malfunction2 inspections
- Design verification - Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2024 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1240926 |
| January 3, 2018 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1036654 |
| March 17, 2016 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 963291 |
| September 11, 2013 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 848319 |
| September 26, 2011 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 746701 |
| June 15, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 667059 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Medtronic Navigation, Inc.-Boxborough
FEI Number
3004785967
Address
200 Beaver Brook Road, Boxborough, Massachusetts 01719, United States
Country
United States
ID: e864dd74-6f9e-4fc1-a677-017f22994700