Company
United StatesMedtronic Perfusion Systems, Brooklyn Park, MN – FDA Inspections
Inspection records and compliance data for Medtronic Perfusion Systems in Brooklyn Park, Minnesota. 8 FDA inspections on record, last inspected June 23, 2022.
Company Profile
This profile covers Medtronic Perfusion Systems based in Brooklyn Park, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 7
- Form 483s
- 0
- Warning letters
- 0
First inspected January 23, 2009. Last inspected June 23, 2022.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Individual Report of Malfunction1 inspection
- Investigation of device failures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 23, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1178299 |
| September 30, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 987452 |
| June 24, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 886720 |
| February 12, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 867900 |
| April 1, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 831904 |
| January 23, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 764709 |
| June 15, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 667045 |
| January 23, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 559235 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medtronic Perfusion Systems
FEI Number
1000116158
Address
7611 Northland Dr N, Brooklyn Park, Minnesota 55428, United States
Country
United States
ID: 213f3751-a903-4fee-af09-e7e6ee04e728