Company
United StatesInfraredx, Inc., Bedford, MA – FDA Inspections
Inspection records and compliance data for Infraredx, Inc. in Bedford, Massachusetts. 7 FDA inspections on record, last inspected March 04, 2025.
Company Profile
This profile covers Infraredx, Inc. based in Bedford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected October 29, 2009. Last inspected March 4, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Failure to submit1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1263539 |
| January 9, 2024 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1227468 |
| December 8, 2021 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1159190 |
| June 2, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1013359 |
| April 10, 2015 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 924454 |
| November 15, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 808572 |
| October 29, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 630365 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Infraredx, Inc.
FEI Number
3015551113
Address
28 Crosby Dr Ste 100, Bedford, Massachusetts 01730, United States
Country
United States
ID: 5f598ed1-9b87-414f-89b6-347cb8ce82c9