FDA Inspection
Cardiovascular Systems IncCardiovascular Systems Inc – FDA Inspection, Oct 24, 2014
Record Details
This FDA Inspection record concerns Cardiovascular Systems Inc, with an inspection on October 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardiovascular Systems Inc
- Inspection Date
- October 24, 2014
- Product Type
- Devices
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ID · b0f89c39-1a54-4407-85f3-37471054f692
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904900
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Cardiovascular Systems Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 1, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 19, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 27, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Cardiovascular Systems Inc
- FDA Inspection 1196016 - 2022-12-14
- FDA Inspection 990253 - 2016-09-01
- FDA Inspection 946122 - 2015-09-25
- FDA Inspection 812699 - 2012-12-19
- FDA Inspection 801804 - 2012-09-27
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