Company
ItalyKedrion S.p.A., Bolognana, Italy – FDA Inspections
Inspection records and compliance data for Kedrion S.p.A. in Bolognana. 6 FDA inspections on record, last inspected April 10, 2025.
Company Profile
This profile covers Kedrion S.p.A. based in Bolognana, Italy.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 18, 2012. Last inspected April 10, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Calibration/Inspection/Checking not done1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 10, 2025 | Not classified | Biologics | 1281078 |
| August 28, 2024 | Not classified | Biologics | 1254229 |
| June 24, 2022 | VAI | Biologics · Blood and Blood Products | 1173210 |
| September 16, 2016 | VAI | Biologics · Vaccines and Allergenic Products | 990289 |
| June 27, 2014 | VAI | Biologics · Blood and Blood Products | 907163 |
| April 18, 2012 | VAI | Biologics · Blood and Blood Products | 785499 |
FDA documents
Form 483s (1)
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Company Information
Name
Kedrion S.p.A.
FEI Number
3008919567
Address
Via Di Fondovalle, Bolognana, Italy
Country
Italy
ID: 89fc7c0d-2ee3-4276-a2ee-e1ba98605ef9