FDA Inspection
Medtronic Advanced Energy LLCMedtronic Advanced Energy LLC – FDA Inspection, Aug 18, 2010
Record Details
This FDA Inspection record concerns Medtronic Advanced Energy LLC, with an inspection on August 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 18, 2010
- Product Type
- Devices
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ID · a09adfec-d302-44b5-bd64-d31774bb5796
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 677087
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Medtronic Advanced Energy LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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