FDA Inspection
Guidemia Technologies Inc.Guidemia Technologies Inc. – FDA Inspection, Jul 6, 2026
Record Details
This FDA Inspection record concerns Guidemia Technologies Inc., with an inspection on July 6, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · db5d20bc-23f8-4387-8e18-4f46d7dcf127
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1325530
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- 21 CFR 830GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
- ISO 13485:2016 Clause 6.2(a)Personnel training not provided
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Guidemia Technologies Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2017 | Not classified | Los Angeles District Office | |
| December 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Guidemia Technologies Inc.
- FDA Inspection 1081235 - 2019-02-11
- FDA Inspection 1021559 - 2017-07-03
- FDA Inspection 859270 - 2013-12-12
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