Company
ItalyGlaxoSmithKline Vaccines S.r.l., Siena, Italy – FDA Inspections
Inspection records and compliance data for GlaxoSmithKline Vaccines S.r.l. in Siena. 4 FDA inspections on record, 2 Form 483s, last inspected January 26, 2024.
Company Profile
This profile covers GlaxoSmithKline Vaccines S.r.l. based in Siena, Italy.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 18, 2010. Last inspected January 26, 2024.
Most cited issue areas
- Cleaning SOPs/schedules1 inspection
- Control procedures to monitor and validate performance1 inspection
- Seed lots1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 26, 2024 | Not classified | Biologics | 1233226 |
| June 6, 2019 | Not classified | Biologics · Vaccines and Allergenic Products | 1092010 |
| May 29, 2017 | VAI | Biologics · Vaccines and Allergenic Products | 1030020 |
| June 18, 2010 | VAI | Biologics · Vaccines and Allergenic Products | 683109 |
FDA documents
Form 483s (1)
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Company Information
Name
GlaxoSmithKline Vaccines S.r.l.
FEI Number
3007780504
Address
Via Fiorentina 1, Siena, Italy
Country
Italy
ID: cddb07b7-c8a6-4dbd-a92c-c6ebeeb7e009