Company
ItalyElcam Medical Italy SPA, Carpi, Italy – FDA Inspections
Inspection records and compliance data for Elcam Medical Italy SPA in Carpi. 4 FDA inspections on record (1 OAI), last inspected December 14, 2022.
Company Profile
This profile covers Elcam Medical Italy SPA based in Carpi, Italy.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected July 9, 2009. Last inspected December 14, 2022.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Personnel1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1195406 |
| May 31, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1060877 |
| September 22, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 747430 |
| July 9, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 597361 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elcam Medical Italy SPA
FEI Number
3004960482
Address
Via Emilia Romagna 15, Carpi, Italy
Country
Italy
ID: ed5ad5f1-b14f-4193-b25d-a1d648a4398c