FDA Inspection
Medifocus, Inc.Medifocus, Inc. – FDA Inspection, Feb 21, 2019
Record Details
This FDA Inspection record concerns Medifocus, Inc., with an inspection on February 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ebdc5e9b-22f8-4c23-b75c-96e6743590f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080032
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medifocus, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medifocus, Inc.
- FDA Inspection 953902 - 2015-12-03
- FDA Inspection 828779 - 2013-04-26
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