FDA Inspection
A7 Precision Machine Technology Inc.A7 Precision Machine Technology Inc. – FDA Inspection, Dec 12, 2012
Record Details
This FDA Inspection record concerns A7 Precision Machine Technology Inc., with an inspection on December 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 12, 2012
- Product Type
- Devices
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ID · bf3fd556-2801-42f7-b3b5-5120759de300
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810314
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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