Company
ItalyAlfasigma S.p.A., Pomezia, Italy – FDA Inspections
Inspection records and compliance data for Alfasigma S.p.A. in Pomezia. 6 FDA inspections on record, 2 Form 483s, last inspected January 26, 2024.
Company Profile
This profile covers Alfasigma S.p.A. based in Pomezia, Italy.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 16, 2011. Last inspected January 26, 2024.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Clothing appropriate for duties performed1 inspection
- Environmental Monitoring System1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 26, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1293602 |
| May 28, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1202245 |
| June 21, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1056604 |
| June 30, 2017 | Not classified | Human Drugs | 1023437 |
| November 10, 2015 | VAI | Human Drugs · Drug Quality Assurance | 951583 |
| September 16, 2011 | VAI | Human Drugs · Drug Quality Assurance | 748680 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Alfasigma S.p.A.
FEI Number
3002808171
Address
Via Pontina Km. 30,400, Pomezia, Italy
Country
Italy
ID: 8553841e-f6ef-48be-84ce-2432492c889b