FDA Inspection
MelunaFDA Inspection 1031662 - Meluna - November 09, 2017
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Record Details
This FDA Inspection record concerns Meluna, with an inspection on November 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 47bc9eae-cb28-41a7-8bd9-c471263f4522
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031662
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Meluna
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| February 16, 2023 | Not classified | Office of Inspections and Investigations |