FDA Inspection
Medtronic Mexico, S. De R. L. De C.V.Medtronic Mexico, S. De R. L. De C.V. – FDA Inspection, Apr 30, 2015
Record Details
This FDA Inspection record concerns Medtronic Mexico, S. De R. L. De C.V., with an inspection on April 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 30, 2015
- Product Type
- Devices
View Company Profile
ID · 19e00673-404a-4ecd-9be3-7b5873fa0ec6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932665
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Mexico, S. De R. L. De C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 15, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 3, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medtronic Mexico, S. De R. L. De C.V.
- FDA Inspection 976870 - 2016-02-18
- FDA Inspection 851866 - 2013-08-15
- FDA Inspection 633456 - 2009-12-03
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