FDA Inspection 1306914 — Steris S.P.A.
The FDA completed an inspection of Steris S.P.A. on Mar 5, 2026 in Calcinate. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Calcinate (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 23189 | ISO 13485:2016 Clause 7.5.11 | Procedures for preserving the conformity of product not documented |