FDA Inspection
Wellell IncWellell Inc – FDA Inspection, May 5, 2017
Record Details
This FDA Inspection record concerns Wellell Inc, with an inspection on May 5, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 78394ccb-d3c1-4f25-bf65-41ccaea7a82d
Inspection Facts
- Inspection number
- 1013148
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Wellell Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wellell Inc
- FDA Inspection 906360 - 2014-11-07
- FDA Inspection 773367 - 2012-02-23
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