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Glaxo Operations UK Ltd.

FDA Regulatory Profile

Glaxo Operations UK Ltd. has 0 FDA recalls, 20 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Glaxo Operations UK Ltd." and its spelling variants "Glaxo Operations Uk", "Glaxo Operations Uk Limited". Records filed under related names are not included; see Related names.

Latest inspection
Mar 12, 2026 · VAI

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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
Inspections20Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Glaxo Operations UK Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Glaxo Operations UK Ltd.: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 2 inspections220192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202410000
202300000
202210000
202110000
202000000
201920000
201800000
201720000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

20 inspections from Jul 21, 2009 to Mar 12, 2026.

DateSiteProductClassificationFEI
Mar 12, 2026Stevenage, United KingdomDrugsVoluntary Action Indicated (VAI)3009763376
Dec 6, 2024Ware, United KingdomDrugsVoluntary Action Indicated (VAI)3003262904
Sep 1, 2022Montrose, United KingdomDrugsVoluntary Action Indicated (VAI)3003215057
May 26, 2021Stevenage, United KingdomDrugsVoluntary Action Indicated (VAI)3009763376
Sep 6, 2019Ware, United KingdomDrugsVoluntary Action Indicated (VAI)3003262904
Jan 25, 2019Ware, United KingdomDrugsVoluntary Action Indicated (VAI)3003262904
May 25, 2017Ulverston, United KingdomDrugsVoluntary Action Indicated (VAI)3003722404
May 16, 2017Stevenage, United KingdomDrugsVoluntary Action Indicated (VAI)3009763376
Jun 20, 2016Ulverston, United KingdomDrugsVoluntary Action Indicated (VAI)3003722404
Jun 10, 2016Montrose, United KingdomDrugsNo Action Indicated (NAI)3003215057
Jul 10, 2015Ware, United KingdomDrugsNo Action Indicated (NAI)3003262904
Sep 12, 2014Ware, United KingdomDrugsNo Action Indicated (NAI)3003262904
Apr 4, 2014Ulverston, United KingdomDrugsVoluntary Action Indicated (VAI)3003722404
May 31, 2013Montrose, United KingdomDrugsVoluntary Action Indicated (VAI)3003215057
Apr 25, 2013Ware, United KingdomDrugsVoluntary Action Indicated (VAI)3003262904
Mar 22, 2013Stevenage, United KingdomDrugsNo Action Indicated (NAI)3009763376
Mar 30, 2012Ware, United KingdomDrugsVoluntary Action Indicated (VAI)3003262904
Sep 9, 2011Ulverston, United KingdomDrugsVoluntary Action Indicated (VAI)3003722404
Dec 14, 2009Montrose, United KingdomDrugsVoluntary Action Indicated (VAI)3003215057
Jul 21, 2009Ware, United KingdomDrugsNo Action Indicated (NAI)3003262904
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

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3009763376Stevenage, United Kingdom4Mar 12, 2026
FEI 3003262904Ware, United Kingdom8Dec 6, 2024
FEI 3003215057Montrose, United Kingdom4Sep 1, 2022
FEI 3003722404Ulverston, United Kingdom4May 25, 2017

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.