Company
ItalySMITHS MEDICAL ITALIA SRL, Sermoneta, Italy – FDA Inspections
Inspection records and compliance data for SMITHS MEDICAL ITALIA SRL in Sermoneta. 3 FDA inspections on record, last inspected March 02, 2023.
Company Profile
This profile covers SMITHS MEDICAL ITALIA SRL based in Sermoneta, Italy.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 26, 2016. Last inspected March 2, 2023.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 2, 2023 | Not classified | Medical Devices & Rad Health | 1203860 |
| November 8, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1074879 |
| May 26, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 976710 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SMITHS MEDICAL ITALIA SRL
FEI Number
3004187702
Address
Via Della Stazione 2, Sermoneta, Italy
Country
Italy
ID: f0009108-fb82-46ca-bbc9-bc4e5a77f589