Company
ItalyItalfarmaco S.p.A., Milan, Italy – FDA Inspections
Inspection records and compliance data for Italfarmaco S.p.A. in Milan. 6 FDA inspections on record, 1 Form 483, last inspected June 28, 2023.
Company Profile
This profile covers Italfarmaco S.p.A. based in Milan, Italy.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected October 28, 2011. Last inspected June 28, 2023.
Most cited issue areas
- Manufacturing Instructions and Specifications1 inspection
- Procedures not in writing, fully followed1 inspection
- Stability sample storage conditions described1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1250897 |
| February 1, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1123970 |
| September 18, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1065965 |
| March 13, 2015 | VAI | Human Drugs · Drug Quality Assurance | 919373 |
| April 11, 2014 | NAI | Human Drugs · Drug Quality Assurance | 880378 |
| October 28, 2011 | NAI | Human Drugs · Drug Quality Assurance | 753752 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- Health Canada · 3 inspections · last March 22, 2016
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Italfarmaco S.p.A.
FEI Number
1196
Address
Viale Fulvio Testi 330, Milan, Italy
Country
Italy
ID: 43c36cab-e301-4482-b9f7-b042cce56271