FDA Inspection
Cardiac Designs Inc.Cardiac Designs Inc. – FDA Inspection, Jun 29, 2016
Record Details
This FDA Inspection record concerns Cardiac Designs Inc., with an inspection on June 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardiac Designs Inc.
- Inspection Date
- June 29, 2016
- Product Type
- Devices
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ID · 9b0a77a1-7f80-4b29-a210-bb755c3ca9e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976041
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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