Company
MexicoMedtronic Mexico, S. De R. L. De C.V., Tijuana, Mexico – FDA Inspections
Inspection records and compliance data for Medtronic Mexico, S. De R. L. De C.V. in Tijuana. 4 FDA inspections on record, last inspected February 18, 2016.
Company Profile
This profile covers Medtronic Mexico, S. De R. L. De C.V. based in Tijuana, Mexico.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected December 3, 2009. Last inspected February 18, 2016.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Nonconforming product control1 inspection
- Statistical techniques - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 18, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 976870 |
| April 30, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 932665 |
| August 15, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 851866 |
| December 3, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 633456 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medtronic Mexico, S. De R. L. De C.V.
FEI Number
3002534070
Address
Paseo Cucapah 10510, Col. El Lago, Tijuana, Tijuana, Mexico
Country
Mexico
ID: 9b9e5b16-2df0-4668-8228-7a4d67dc5355