FDA Inspection
MelunaFDA Inspection 1198212 - Meluna - February 16, 2023
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Record Details
This FDA Inspection record concerns Meluna, with an inspection on February 16, 2023, issued by the Office of Inspections and Investigations.
- Company
- Meluna
- Inspection Date
- February 16, 2023
View Company Profile
ID · 3357c638-85ed-46fc-bbb8-2d88dba2086a
Inspection Facts
- Inspection number
- 1198212
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR content
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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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 |
| November 9, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |