FDA Inspection
Cadwell Industries IncCadwell Industries Inc – FDA Inspection, Aug 16, 2017
Record Details
This FDA Inspection record concerns Cadwell Industries Inc, with an inspection on August 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fcb70663-610f-4f63-ad8e-8742e79a4b5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023280
- 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)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Cadwell Industries Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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