FDA Inspection
The Soule CompanyThe Soule Company – FDA Inspection, Feb 13, 2018
Record Details
This FDA Inspection record concerns The Soule Company, with an inspection on February 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 552e086c-fb90-450f-9b3c-bd98071d477b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042004
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training records
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Other FDA inspections of The Soule Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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