FDA Inspection
Heart Smart IncHeart Smart Inc – FDA Inspection, Feb 21, 2017
Record Details
This FDA Inspection record concerns Heart Smart Inc, with an inspection on February 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 32354f3c-89b5-41b6-9a78-ace3fc68ec21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003097
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Heart Smart Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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