FDA Inspection
GlaxoSmithKline Vaccines S.r.l.GlaxoSmithKline Vaccines S.r.l. – FDA Inspection, Jun 6, 2019
Record Details
This FDA Inspection record concerns GlaxoSmithKline Vaccines S.r.l., with an inspection on June 6, 2019, issued by the Office of Inspections and Investigations, covering biologics.
- People
- Darla J. Christopher (FDA Associated Person)
- Omotunde O. Osunsanmi (Issuing Officer)
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ID · c8ccef32-95e1-48e2-9a17-8596412e1bbb
Inspection Facts
- Inspection number
- 1092010
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 610.18(b)Seed lots
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Other FDA inspections of GlaxoSmithKline Vaccines S.r.l.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2024 | Not classified | Office of Inspections and Investigations | |
| May 29, 2017 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 18, 2010 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for GlaxoSmithKline Vaccines S.r.l.
- FDA Inspection 1233226 - 2024-01-26
- FDA Inspection 1030020 - 2017-05-29
- FDA Inspection 683109 - 2010-06-18
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