FDA Inspection
Total Vein SystemsTotal Vein Systems – FDA Inspection, Oct 9, 2015
Record Details
This FDA Inspection record concerns Total Vein Systems, with an inspection on October 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Total Vein Systems
- Inspection Date
- October 9, 2015
- Product Type
- Devices
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ID · a8f9a343-c800-4570-b1cd-f56191d037a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945315
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 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 Total Vein Systems
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Total Vein Systems
- FDA Inspection 1070666 - 2018-11-02
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