FDA Inspection
Torbot Group, Inc.Torbot Group, Inc. – FDA Inspection, Mar 2, 2012
Record Details
This FDA Inspection record concerns Torbot Group, Inc., with an inspection on March 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Torbot Group, Inc.
- Inspection Date
- March 2, 2012
- Product Type
- Devices
View Company Profile
ID · 8fa3ee55-f495-4c0e-aa4e-9d42014fcd93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.86Acceptance status
- 21 CFR 806.10(c)(7)Event description
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Torbot Group, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 23, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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