Company
ItalyEltech s.r.l., Treviso, Italy – FDA Inspections
Inspection records and compliance data for Eltech s.r.l. in Treviso. 2 FDA inspections on record (1 OAI), last inspected August 29, 2014.
Company Profile
This profile covers Eltech s.r.l. based in Treviso, Italy.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2010. Last inspected August 29, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - documentation1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 894884 |
| December 9, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 701343 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Eltech s.r.l.
FEI Number
3004642415
Address
Via Castagnole 20-H, Treviso, Italy
Country
Italy
ID: 4d6ef59d-8e3f-49e1-a3d7-a8c8cad97362