GlaxoSmithKline Research & Development Limited FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "GlaxoSmithKline Research & Development Limited" and its spelling variant "Glaxosmithkline Research And Development Limited". Records filed under related names are not included; see Related names.

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

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

4 inspections from Dec 17, 2009 to May 16, 2017.

DateSiteProductClassificationFEI
May 16, 2017Stevenage, United KingdomDrugsVoluntary Action Indicated (VAI)3003284850
Jun 24, 2016Stevenage, United KingdomDrugsVoluntary Action Indicated (VAI)3003284850
Oct 11, 2012Stevenage, United KingdomDrugsVoluntary Action Indicated (VAI)3003284850
Dec 17, 2009Stevenage, United KingdomDrugsVoluntary 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003284850Stevenage, United Kingdom4May 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.