FDA Inspection
Medtronic Advanced Energy LLCMedtronic Advanced Energy LLC – FDA Inspection, Jul 3, 2012
Record Details
This FDA Inspection record concerns Medtronic Advanced Energy LLC, with an inspection on July 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 3, 2012
- Product Type
- Devices
View Company Profile
ID · 723f3889-5175-44c7-acea-e19ed837f877
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789244
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 806.20(a)Records not kept
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Other FDA inspections of Medtronic Advanced Energy LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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