Company
ItalySteris S.p.A. - Inspection Records
Inspection records and compliance data for Steris S.p.A. in Seriate. 2 FDA inspections on record, 1 Form 483, last inspected February 26, 2026.
Company Profile
This profile covers Steris S.p.A. based in Seriate, Italy.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 12, 2013. Last inspected February 26, 2026.
Most cited issue areas
- Risk-based approach not applied to QMS processes1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 26, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1306916 |
| September 12, 2013 | NAI | Human Drugs · Drug Quality Assurance | 851399 |
FDA documents
Form 483s (1)
Company Information
Name
Steris S.p.A.
FEI Number
3002806470
Address
Via Ca' Bertoncina 29, Seriate, Italy
Country
Italy
ID: 0411b122-8818-4f0c-82da-9d906deb7ebd