GlaxoSmithKline Research & Development Limited FDA Record
GlaxoSmithKline Research & Development Limited has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GlaxoSmithKline Research & Development Limited" is on file.
- Latest recall
- D-0544-2024 · May 17, 2024 · filed under Glaxosmithkline
- Latest inspection
- May 16, 2017 · VAI
Newer recall under related name Glaxosmithkline: May 17, 2024, D-0544-2024.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 16, 2017 | Stevenage, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003284850 |
| Jun 24, 2016 | Stevenage, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003284850 |
| Oct 11, 2012 | Stevenage, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003284850 |
| Dec 17, 2009 | Stevenage, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3003284850 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003284850 | Stevenage, United Kingdom | 4 | May 16, 2017 |
GlaxoSmithKline Research & Development Limited and the FDA: common questions
Has GlaxoSmithKline Research & Development Limited received an FDA warning letter?
No FDA warning letter addressed to the name "GlaxoSmithKline Research & Development Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has GlaxoSmithKline Research & Development Limited received an FDA Form 483?
FDA has not published a Form 483 for "GlaxoSmithKline Research & Development Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GlaxoSmithKline Research & Development Limited?
The most recent FDA inspection on file ended May 16, 2017 at Stevenage, United Kingdom and was classified VAI. FDA has 4 inspections of GlaxoSmithKline Research & Development Limited on file.
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