FDA Inspection
Advanced Rehabilitation TechnologiesAdvanced Rehabilitation Technologies – FDA Inspection, Oct 16, 2009
Record Details
This FDA Inspection record concerns Advanced Rehabilitation Technologies, with an inspection on October 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 16, 2009
- Product Type
- Devices
View Company Profile
ID · 35529897-0aff-439c-8f82-c7b217220999
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628007
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Advanced Rehabilitation Technologies
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Rehabilitation Technologies
- FDA Inspection 890732 - 2014-08-06
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