FDA Inspection
Wound Care 360 LLCWound Care 360 LLC – FDA Inspection, May 15, 2014
Record Details
This FDA Inspection record concerns Wound Care 360 LLC, with an inspection on May 15, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wound Care 360 LLC
- Inspection Date
- May 15, 2014
- Product Type
- Devices
View Company Profile
ID · 0219075c-af10-43db-bd00-3f48ca80ac8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 878607
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(4)Availability of records of non-significant risk studies
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