FDA Inspection
Medifocus, Inc.Medifocus, Inc. – FDA Inspection, Dec 3, 2015
Record Details
This FDA Inspection record concerns Medifocus, Inc., with an inspection on December 3, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medifocus, Inc.
- Inspection Date
- December 3, 2015
- Product Type
- Devices
View Company Profile
ID · 722bba86-5329-4142-9eaf-ddcc16f6303d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953902
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Medifocus, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2019 | 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 1080032 - 2019-02-21
- FDA Inspection 828779 - 2013-04-26
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