FDA Inspection
MelunaFDA Inspection 1309934 - Meluna - February 26, 2026
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Record Details
This FDA Inspection record concerns Meluna, with an inspection on February 26, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d1cee2f1-9396-459c-8333-535664168426
Inspection Facts
- Inspection number
- 1309934
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- ISO 13485:2016 Clause 5.5.1Management responsibilities and authorities not documented
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.11Procedures for preserving the conformity of product not documented
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 7.6Equipment calibration or verification not performed
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Meluna
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2023 | Not classified | Office of Inspections and Investigations | |
| November 9, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |