FDA Inspection
Mectronic Medicale S.R.L.Mectronic Medicale S.R.L. – FDA Inspection, Feb 27, 2025
Record Details
This FDA Inspection record concerns Mectronic Medicale S.R.L., with an inspection on February 27, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Mectronic Medicale S.R.L.
- Inspection Date
- February 27, 2025
- Product Type
- Medical Devices & Rad Health
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ID · d96b45f1-ad83-493c-a6c6-35ea424b1c8b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1262168
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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