Company
United StatesCardiovascular Systems Inc, Saint Paul, MN – FDA Inspections
Inspection records and compliance data for Cardiovascular Systems Inc in Saint Paul, Minnesota. 7 FDA inspections on record, last inspected December 14, 2022.
Company Profile
This profile covers Cardiovascular Systems Inc based in Saint Paul, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2010. Last inspected December 14, 2022.
Most cited issue areas
- Design output - documentation1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1196016 |
| September 1, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 990253 |
| September 25, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 946122 |
| October 24, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 904900 |
| December 19, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 812699 |
| September 27, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 801804 |
| August 5, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 674161 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cardiovascular Systems Inc
FEI Number
3004742232
Address
1225 Old Highway 8 NW, Saint Paul, Minnesota 55112, United States
Country
United States
ID: 7bf2fe5d-c625-46be-90f7-8e6aa5aea49b