FDA Inspection
Cardiovascular Imaging Technologies, LLC.Cardiovascular Imaging Technologies, LLC. – FDA Inspection, Sep 8, 2009
Record Details
This FDA Inspection record concerns Cardiovascular Imaging Technologies, LLC., with an inspection on September 8, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 8, 2009
- Product Type
- Devices
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ID · f3da15d6-d2b1-4227-b3a0-6c1e560569fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610037
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.198(e)(7)Corrective action taken
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Other FDA inspections of Cardiovascular Imaging Technologies, LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 5, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cardiovascular Imaging Technologies, LLC.
- FDA Inspection 1233607 - 2024-03-18
- FDA Inspection 1067868 - 2018-10-05
- FDA Inspection 843272 - 2013-08-08
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