FDA Inspection
Dane TechnologiesDane Technologies – FDA Inspection, Aug 25, 2025
Record Details
This FDA Inspection record concerns Dane Technologies, with an inspection on August 25, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.
View Company Profile
ID · d144259d-d1b9-4d9e-b83c-609671131780
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280320
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dane Technologies
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dane Technologies
- FDA Inspection 1165291 - 2022-03-18
- FDA Inspection 1049814 - 2018-04-27
- FDA Inspection 805861 - 2012-10-17
- FDA Inspection 671007 - 2010-06-17
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.