FDA Inspection
The Soule CompanyThe Soule Company – FDA Inspection, Apr 20, 2011
Record Details
This FDA Inspection record concerns The Soule Company, with an inspection on April 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Soule Company
- Inspection Date
- April 20, 2011
- Product Type
- Devices
View Company Profile
ID · 6bb36e75-84b4-460f-a698-48f672ba26fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 721205
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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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 |
| March 19, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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