FDA Inspection
The Soule CompanyThe Soule Company – FDA Inspection, Mar 19, 2010
Record Details
This FDA Inspection record concerns The Soule Company, with an inspection on March 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Soule Company
- Inspection Date
- March 19, 2010
- Product Type
- Devices
View Company Profile
ID · 6a373392-cad1-41cf-b686-621d741468c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652112
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.181(b)DMR production process specifications
- 21 CFR 820.100(a)(4)Verify, validate change {see also 820.100(a)}
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Other FDA inspections of The Soule Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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