FDA Inspection
SBM SISTEMI S.R.L.SBM SISTEMI S.R.L. – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns SBM SISTEMI S.R.L., with an inspection on September 3, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 9e5a7cfa-049b-448e-8b97-3c3ca664c03a
Inspection Facts
- Inspection number
- 1334172
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.2.4Document changes not appropriately reviewed and approved
- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
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