FDA Inspection
CardiosolutionsCardiosolutions – FDA Inspection, Dec 10, 2012
Record Details
This FDA Inspection record concerns Cardiosolutions, with an inspection on December 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardiosolutions
- Inspection Date
- December 10, 2012
- Product Type
- Devices
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ID · ea342a93-4a27-4bea-9a6e-ee0383b795ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808896
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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