Company
ItalySanofi S.r.l., Anagni, Italy – FDA Inspections
Inspection records and compliance data for Sanofi S.r.l. in Anagni. 11 FDA inspections on record, 3 Form 483s, last inspected June 21, 2024.
Company Profile
This profile covers Sanofi S.r.l. based in Anagni, Italy.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 7
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected June 23, 2011. Last inspected June 21, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 21, 2024 | NAI | Biologics · Blood and Blood Products | 1234890 |
| May 22, 2023 | Not classified | Human Drugs | 1219964 |
| February 2, 2023 | Not classified | Medical Devices & Rad Health | 1198108 |
| November 18, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1205901 |
| April 5, 2019 | Not classified | Human Drugs | 1088414 |
| February 15, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1123330 |
| May 31, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1055081 |
| July 29, 2016 | VAI | Human Drugs · Drug Quality Assurance | 988968 |
| September 26, 2014 | VAI | Human Drugs · Drug Quality Assurance | 900038 |
| March 22, 2012 | VAI | Human Drugs · Drug Quality Assurance | 774759 |
| June 23, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 734695 |
FDA documents
Form 483s (2)
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Company Information
Name
Sanofi S.r.l.
FEI Number
3002807108
Address
Via Valcanello 4, Anagni, Italy
Country
Italy
ID: 54ba861a-36eb-4486-a4ba-2a8194cdf7a5