FDA Inspection
Guidemia Technologies Inc.Guidemia Technologies Inc. – FDA Inspection, Dec 12, 2013
Record Details
This FDA Inspection record concerns Guidemia Technologies Inc., with an inspection on December 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guidemia Technologies Inc.
- Inspection Date
- December 12, 2013
- Product Type
- Devices
View Company Profile
ID · ff06699e-4f86-435c-8205-b3bdbee07fb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859270
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)General
- 21 CFR 803.17(b)(2)Reports and information documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Guidemia Technologies Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2026 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 11, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2017 | Not classified | Los Angeles District Office |
Other documents for Guidemia Technologies Inc.
- FDA Inspection 1325530 - 2026-07-06
- FDA Inspection 1081235 - 2019-02-11
- FDA Inspection 1021559 - 2017-07-03
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