FDA Inspection
Refine USA, LLCRefine USA, LLC – FDA Inspection, Apr 18, 2018
Record Details
This FDA Inspection record concerns Refine USA, LLC, with an inspection on April 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8f893699-8f3d-4230-b4cb-a24bb66f41a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049482
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Refine USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Refine USA, LLC
- FDA Inspection 1215028 - 2023-08-16
- FDA Inspection 852060 - 2013-10-04
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