FDA Inspection
Medical Facets NC LLCMedical Facets NC LLC – FDA Inspection, Mar 4, 2016
Record Details
This FDA Inspection record concerns Medical Facets NC LLC, with an inspection on March 4, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Facets NC LLC
- Inspection Date
- March 4, 2016
- Product Type
- Devices
View Company Profile
ID · bde659a5-3f4a-4e37-9056-ab6a5264d870
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968355
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(b)Supplier notification of changes
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