FDA Inspection
Zefon InternationalZefon International – FDA Inspection, Feb 11, 2010
Record Details
This FDA Inspection record concerns Zefon International, with an inspection on February 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zefon International
- Inspection Date
- February 11, 2010
- Product Type
- Devices
View Company Profile
ID · aea57a0d-6000-4fa1-8358-f5a80fced781
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645512
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(e)(6)Results of investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zefon International
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zefon International
- FDA Inspection 816924 - 2013-01-31
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