FDA Inspection
Steris S.p.A.FDA Inspection 1306916 - Steris S.p.A. - February 26, 2026
Record Details
This FDA Inspection record concerns Steris S.p.A., 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 · a2170942-760d-4ff1-8f9f-ac5b2f9f0b30
Inspection Facts
- Inspection number
- 1306916
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
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Other FDA inspections of Steris S.p.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Steris S.p.A.
- FDA Inspection 851399 - 2013-09-12
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