FDA Inspection
Wellell IncWellell Inc – FDA Inspection, Feb 23, 2012
Record Details
This FDA Inspection record concerns Wellell Inc, with an inspection on February 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wellell Inc
- Inspection Date
- February 23, 2012
- Product Type
- Devices
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ID · a8acef32-8bf7-46a8-92f3-a156bae96385
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773367
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Wellell Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| November 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wellell Inc
- FDA Inspection 1013148 - 2017-05-05
- FDA Inspection 906360 - 2014-11-07
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