FDA Inspection
MEDICA S.p.A. Socio UnicoMEDICA S.p.A. Socio Unico – FDA Inspection, May 26, 2026
Record Details
This FDA Inspection record concerns MEDICA S.p.A. Socio Unico, with an inspection on May 26, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · be1bde31-b147-489c-9005-ff87c02aae66
Inspection Facts
- Inspection number
- 1318908
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.35(a)Records of complaint investigations do not include required information
- ISO 13485:2016 Clause 6.1(b)Resources for meeting regulatory and customer requirements not provided
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of MEDICA S.p.A. Socio Unico
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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