FDA Inspection
Minnetronix, Inc.Minnetronix, Inc. – FDA Inspection, Apr 1, 2026
Record Details
This FDA Inspection record concerns Minnetronix, Inc., with an inspection on April 1, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · d2137322-ce03-4bbd-a4d2-d92a763e760f
Inspection Facts
- Inspection number
- 1310502
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Minnetronix, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2025 | Not classified | Minneapolis District Office | |
| August 8, 2023 | Not classified | Minneapolis District Office | |
| December 8, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 10, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Minnetronix, Inc.
- FDA Inspection 1272311 - 2025-06-04
- FDA Inspection 1215791 - 2023-08-08
- FDA Inspection 1192937 - 2022-12-08
- FDA Inspection 1089675 - 2019-04-10
- FDA Inspection 1016466 - 2017-05-11
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