FDA Inspection
Infraredx, Inc.Infraredx, Inc. – FDA Inspection, Nov 15, 2012
Record Details
This FDA Inspection record concerns Infraredx, Inc., with an inspection on November 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Infraredx, Inc.
- Inspection Date
- November 15, 2012
- Product Type
- Devices
View Company Profile
ID · 7ba63d91-abd5-4900-b543-24898c654e64
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808572
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 1002.13Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Infraredx, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2024 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 8, 2021 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 2, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Infraredx, Inc.
- FDA Inspection 1263539 - 2025-03-04
- FDA Inspection 1227468 - 2024-01-09
- FDA Inspection 1159190 - 2021-12-08
- FDA Inspection 1013359 - 2017-06-02
- FDA Inspection 924454 - 2015-04-10
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