FDA Inspection
Vionic Group LLCVionic Group LLC – FDA Inspection, Oct 12, 2016
Record Details
This FDA Inspection record concerns Vionic Group LLC, with an inspection on October 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89dbe6c7-e446-4f06-8c0a-029e96b40535
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003859
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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