Company
ItalyWyeth Lederle S.r.l, Catania, Italy – FDA Inspections
Inspection records and compliance data for Wyeth Lederle S.r.l in Catania. 5 FDA inspections on record (2 OAI), 1 Form 483, last inspected January 21, 2022.
Company Profile
This profile covers Wyeth Lederle S.r.l based in Catania, Italy.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 4, 2009. Last inspected January 21, 2022.
Most cited issue areas
- Environmental Monitoring System2 inspections
- Procedures for sterile drug products2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 21, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1178127 |
| April 20, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1012188 |
| November 14, 2014 | OAI | Human Drugs · Drug Quality Assurance | 903600 |
| July 20, 2012 | OAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 792624 |
| December 4, 2009 | NAI | Human Drugs · Drug Quality Assurance | 637083 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Wyeth Lederle S.r.l
FEI Number
3002806766
Address
Zona Industriale, Via Franco Gorgone 6A, Catania, Italy
Country
Italy
ID: 9fc09023-829f-4d59-be9b-44097f3d2fff