FDA 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.

Company: Meluna
Inspection Date: February 26, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations

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ID · d1cee2f1-9396-459c-8333-535664168426

Violation Codes9

ISO 13485:2016 Clause 4.2.3ISO 13485:2016 Clause 5.5.1ISO 13485:2016 Clause 7.3.1ISO 13485:2016 Clause 7.5.1ISO 13485:2016 Clause 7.5.11ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 7.6ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.5.2

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