FDA Inspection
Torbot Group, Inc.Torbot Group, Inc. – FDA Inspection, Aug 28, 2014
Record Details
This FDA Inspection record concerns Torbot Group, Inc., with an inspection on August 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Torbot Group, Inc.
- Inspection Date
- August 28, 2014
- Product Type
- Devices
View Company Profile
ID · 47a02c8f-46e2-4b75-977d-9e70d482e24c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893627
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Torbot Group, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2012 | 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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