FDA Inspection
Medical Technologies Unlimited Inc.Medical Technologies Unlimited Inc. – FDA Inspection, Jul 24, 2012
Record Details
This FDA Inspection record concerns Medical Technologies Unlimited Inc., with an inspection on July 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 24, 2012
- Product Type
- Devices
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ID · 925d1b95-48fa-423a-a197-2b3c83b717c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793064
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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