Company
ItalyPatheon Italia S.p.A., Monza E della Brianza, Italy – FDA Inspections
Inspection records and compliance data for Patheon Italia S.p.A. in Monza E della Brianza, 20900. 14 FDA inspections on record, 4 Form 483s, last inspected February 10, 2026.
Company Profile
This profile covers Patheon Italia S.p.A. based in Monza E della Brianza, 20900, Italy.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 0
- VAI
- 9
- NAI
- 2
- Unclassified
- 3
- Form 483s
- 4
- Warning letters
- 0
First inspected July 1, 2009. Last inspected February 10, 2026.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Adequate number of batches on stability1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 10, 2026 | Not classified | Biologics · Vaccines and Allergenic Products | 1304236 |
| September 29, 2023 | VAI | Biologics · Vaccines and Allergenic Products | 1220064 |
| September 5, 2023 | Not classified | Human Drugs | 1223465 |
| May 26, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1206297 |
| January 26, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1238005 |
| April 8, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1206091 |
| July 5, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1130741 |
| November 2, 2018 | Not classified | Human Drugs | 1076223 |
| February 6, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1041862 |
| May 20, 2016 | VAI | Human Drugs · Drug Quality Assurance | 977718 |
| April 8, 2014 | VAI | Human Drugs · Drug Quality Assurance | 877083 |
| June 11, 2013 | VAI | Human Drugs · Drug Quality Assurance | 839378 |
| June 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 733806 |
| July 1, 2009 | NAI | Human Drugs · Drug Quality Assurance | 600753 |
FDA documents
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Company Information
Name
Patheon Italia S.p.A.
FEI Number
3003065803
Address
Monza, Monza E della Brianza, 20900 Italy, Italy
Country
Italy
ID: eb421078-fb58-4c48-a8ae-f1c1befb8145