FDA Inspection
Cardiovascular Systems, Inc.Cardiovascular Systems, Inc. – FDA Inspection, Dec 12, 2014
Record Details
This FDA Inspection record concerns Cardiovascular Systems, Inc., with an inspection on December 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardiovascular Systems, Inc.
- Inspection Date
- December 12, 2014
- Product Type
- Devices
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ID · d77faa01-3d11-49c5-af58-c1598fd2404b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 908364
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cardiovascular Systems, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cardiovascular Systems, Inc.
- FDA Inspection 978650 - 2016-07-12
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