FDA Inspection
Nutronix Revolution, Inc.Nutronix Revolution, Inc. – FDA Inspection, Jun 1, 2015
Record Details
This FDA Inspection record concerns Nutronix Revolution, Inc., with an inspection on June 1, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nutronix Revolution, Inc.
- Inspection Date
- June 1, 2015
- Product Type
- Devices
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ID · f63bd9dd-68d5-45f3-9c20-288dda8647cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923718
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
39- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Nutronix Revolution, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 1, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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