Company
ItalyUNIBELL SRL, Calco, Italy – FDA Inspections
Inspection records and compliance data for UNIBELL SRL in Calco. 1 FDA inspection on record, 1 Form 483, last inspected September 10, 2026.
Company Profile
This profile covers UNIBELL SRL based in Calco, Italy.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 10, 2026.
Most cited issue areas
- Information gathered in feedback process not used as input into risk management1 inspection
- Lack of Written MDR Procedures1 inspection
- Management review output records lack input reviewed, decisions, and actions1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1335056 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
UNIBELL SRL
FEI Number
3007491751
Address
Via Indipendenza 27, Calco, Italy
Country
Italy
ID: 411f5c3e-18e3-42aa-b3ba-4c466c1793e1