FDA Inspection
Footprint Medical, Inc.FDA Inspection 1309394 - Footprint Medical, Inc. - March 26, 2026
Record Details
This FDA Inspection record concerns Footprint Medical, Inc., with an inspection on March 26, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5db99db1-8b1c-4632-bf96-a9daddccb261
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1309394
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Footprint Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 17, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Footprint Medical, Inc.
- FDA Inspection 1208059 - 2023-06-14
- FDA Inspection 1066267 - 2018-09-21
- FDA Inspection 899516 - 2014-09-18
- FDA Inspection 698021 - 2010-11-17
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