Company
GermanySmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals), Dresden, Germany – FDA Inspections
Inspection records and compliance data for SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) in Dresden. 7 FDA inspections on record, 1 Form 483, last inspected March 15, 2024.
Company Profile
This profile covers SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) based in Dresden, Germany.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 6
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 30, 2009. Last inspected March 15, 2024.
Most cited issue areas
- Scientifically sound laboratory controls1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 15, 2024 | VAI | Biologics · Vaccines and Allergenic Products | 1233707 |
| September 20, 2022 | VAI | Biologics · Vaccines and Allergenic Products | 1181891 |
| July 5, 2019 | NAI | Biologics · Vaccines and Allergenic Products | 1101506 |
| June 27, 2017 | VAI | Biologics · Vaccines and Allergenic Products | 1019795 |
| June 22, 2011 | VAI | Biologics · Vaccines and Allergenic Products | 736162 |
| May 24, 2010 | VAI | Biologics · Vaccines and Allergenic Products | 668686 |
| April 30, 2009 | VAI | Biologics · Vaccines and Allergenic Products | 584548 |
FDA documents
Form 483s (1)
People (2)
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Company Information
Name
SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals)
FEI Number
3004835618
Address
Zirkusstr. 40, Dresden, Germany
Country
Germany
ID: 184bcdd6-8f25-45bf-b562-fcb41f6c48f7