Company
United StatesCardiovascular Systems, Inc., Pearland, TX – FDA Inspections
Inspection records and compliance data for Cardiovascular Systems, Inc. in Pearland, Texas. 2 FDA inspections on record, last inspected July 12, 2016.
Company Profile
This profile covers Cardiovascular Systems, Inc. based in Pearland, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 12, 2014. Last inspected July 12, 2016.
Most cited issue areas
- Complaints1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 12, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 978650 |
| December 12, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 908364 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cardiovascular Systems, Inc.
FEI Number
3008814558
Address
14740 Kirby Dr, Pearland, Texas 77047, United States
Country
United States
ID: f026e8c2-c444-47c5-afd6-f3a6f50840df