FDA Inspection
Cardiokinetix IncCardiokinetix Inc – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns Cardiokinetix Inc, with an inspection on November 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Sandra S. Saniga (Issuing Officer)
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ID · efe7adaf-3a22-4a96-a155-8d721903a1a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993139
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
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