Company
ItalyEsaote S.p.A., Florence, Italy – FDA Inspections
Inspection records and compliance data for Esaote S.p.A. in Florence. 1 FDA inspection on record, last inspected December 02, 2010.
Company Profile
This profile covers Esaote S.p.A. based in Florence, Italy.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected December 2, 2010.
Most cited issue areas
- Design validation acceptance criteria1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 2, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 701345 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Esaote S.p.A.
FEI Number
3002806925
Address
Via Di Caciolle 15, Florence, Italy
Country
Italy
ID: 0eddbbce-e3e7-4b38-9a89-62a51685f76a